NRAC Issue #1566	ADDENDUM		February 21, 2006       


    NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION
    THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION
THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C.

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PRODUCT       a) Sigma implantable pulse generators (IPGs)
                 dual Chamber Pacemaker, models SD203, SD303
RECALL NUMBER # Z-0534-06;
PRODUCT       b) Sigma implantable pulse generators (IPGs)
                 Dual Chamber Rate Responsive Pacemaker,
                 models SDR203, SDR303, SDR306
RECALL NUMBER # Z-0535-06;
PRODUCT       c) Sigma implantable pulse generators (IPGs)
                 Dual Chamber Atrial Sensing, Ventricular
                 Sensing and Pacing Pacemaker. Atrial
                 Bipolar sensing connector, ventricular
                 Bipolar connector, model SVDD303
RECALL NUMBER # Z-0536-06;
PRODUCT       d) Sigma implantable pulse generators (IPGs)
                 Single Chamber Pacemaker, models SS103,
                 SS106, SS203, SS303
RECALL NUMBER # Z-0537-06;
PRODUCT       e) Sigma implantable pulse generators (IPGs)
                 Single Chamber Rate Responsive Pacemaker,
                 models SSR203, SSR303, SSR306
RECALL NUMBER # Z-0538-06;
PRODUCT       f) Sigma implantable pulse generators (IPGs)
                 Single Chamber Pacemaker model SVVI103,
                 for ventricular use only
RECALL NUMBER # Z-0539-06
CODE          a) Serial no. PJD182918H - PJD191025H,
                 PJD432660H - PJD449026H, PJD674196S -
                 PJD690881S, PJD731443S - PJD743447S;
                 Serial no. PJD183969H - PJD186285H,
                 PJD187584H - PJD187735H, PJD190274H,
                 PJD190305H, PJD190308H, PJD195395H,
                 PJD195444H, PJD441326 - PJD448026H,
                 PJD674200S - PJD681640S, PJD691135S,
                 PJD691231S, PJD729895S - PJD742209S;
              b) Serial no. PJD183978h - PJD184012h,
                 PJD186200H - PJD186279H, PJD187571H -
                 PJD187669H, PJD193734H, PJD195394H -
                 PJD195470H, PJD442170H, PJD445718H -
                 PJD452929H, PJD674175S - PJD680868S,
                 PJD685590S, PJD689228S, PJD691226S,
                 PJD731742S - PJD739835S.
                 Serial no. PJD182452H - PJD199059H,
                 PJD205280H, PJD440288H - PJD451956H,
                 PJD674216S - PJD691410S, PJD730124S -
                 PJD746998S.
                 Serial no. JE120662H - PJE120706H,
                 PJE620733S - PJE621387S;
              c) Serial no. PJD183400H - PJD183447H,
                 PJD186130H - PJD186199H, PJD188418H -
                 PJD188519H, PJD430299H - PJD430332H,
                 PJD441378H - PJD441396H, PJD442436H -
                 PJD442448H, PJD445371H - PJD448139H,
                 PJD675113S - PJD675193S, PJD675694S -
                 PJD676809S, PJD677182S - PJD677945S,
                 PJD678157S - PJD686906S, PJD730001S -
                 PJD744349S;
              d) Serial no. PJG160592H - PJG161247H,
                 PJG162149H - PJG162607H, PJG163245H -
                 PJG163805H, PJG165759H - PJG168541H,
                 PJG170637H - PJG170921H, PJG428851H -
                 PJG431485H, PJG677154S - PJG748119S,
                 PJG748671S - PJG748710S, PJG748732S -
                 PJG750863S, PJG751336S - PJG751944S,
                 PJG752070S - PJG754744S, PJG231054M -
                 PJG233721M, PJG748407C - PJG748670C,
                 PJG748711C - PJG748722C.
                 Serial no. PJH117098H - PJH118839H,
                 PJH624138S - PJH624610S, PJH626910S -
                 PJH626967S.
                 Serial no. PJG165866H, PJG170641H -
                 PJG170782H, PJG428850H - PJG431464H,
                 PJG676637S - PJG681858S, PJG682490S,
                 PJG683196S, PJG684296S - PJG689861S,
                 PJG695412S, PJG747908S - PJG754745S,
                 PJG231551M - PJG234346M.
                 Serial no. PJG162131H - PJG16371H,
                 PJG427797H - PJG431510H, PJG676969S -
                 PJG691865, PJG740396S - PJG757886S;
              e) Serial no. PJG159204H - PJG178395H,
                 PJG462302H - PJG434280H, PJG740166S -
                 PJG766757S, PJG675988S - PJG694391S.
                 Serial no. PJG159103H, - PJG178395H,
                 PJG426302H - PJG434280H, PJG740166S -
                 PJG766757S, PJG675988S - PJG694391S.
                 Serial no. PJH116644H - PJH118708H,
                 PJH624113S - PJH627050S;
              f) Serial no.PJG159902H - PJG176701H,
                 PJG432779H - PJG432895H, PJG230582M -
                 PJG236398M, PJG677442S - PJG696014S,
                 PJG748310S - PJG755468S, PJG747654C -
                 PJG755171C
MANUFACTURER  Madtronic Med Rel Inc, Humacao, PR
RECALLED BY   Medtronic, Inc., Fridley, MN
QUANTITY      40,595 units
DISTRIBUTION  Nationwide and Internationally
REASON        An issue exists with a specific subset of Sigma series
              pacemakers that may fail due to separation of interconnect wires
              from the hybrid circuit. This failure mechanism may present
              clinically as loss of rate response, premature battery
              depletion, intermittent or total loss of telemetry, or not
              output. There have been no reported patient injuries or deaths
              due to this issue.

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