BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSAFE ENDOCARDIAL PACING LEAD

    MDR report key: 137014 · Received September 26, 1997

    Report

    Report Number
    2522457-1997-00017
    Event Type
    Injury
    Date Received
    September 26, 1997
    Date of Event
    August 13, 1997
    Report Date
    August 14, 1997
    Manufacturer
    CARDIAC CONTROL SYSTEMS, INC
    Product Code
    DTB
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 5/28/97, A 91 Y/O FEMALE PT WAS IMPLANTED WITH A SINGLE-LEAD ATRIAL SYNCHRONOUS VENTRICULAR PACEMAKER SYSTEM. ON 8/14/97, THE MFR RECEIVED A REPORT THAT PT HAD FALLEN AND INTERRUPTED NORMAL OPERATION OF THE PACEMAKER. DR BELIEVED THE LEAD HAD BECOME DISLODGED AND THIS WAS CONFIRMED BY AN X-RAY. ON 8/13/97, DR ELECTED TO REPOSITION THE LEAD AND ACCIDENTALLY CUT IT. A NEW (MODEL# AT-443) LEAD WAS CONNECTED TO THE EXISTING PACEMAKER AND NO ATRIAL TACKING WAS OBSERVED. PROGRAMMING VDD WITH A SHORT AV DELAY DID NOT ELICIT VENTRICULAR PACING. STANDARD VVI PERFORMANCE WAS APPARENT WHEN PROGRAMMED TO VVI. THE LEAD WAS DISCONNECTED FROM THE PACEMAKER AND LEAD CHARACTERISTICS RE-CHECKED. THESE WERE SUBSTANTIALLY SIMILAR TO THE VALUES FIRST OBTAINED. RECONNECTING THE PACER AFTER REVIEW OF SETSCREW PLACEMENT AND POCKET IRRIGATION STILL DID NOT RESULT IN OBSERVED ATRIAL TRACKING. IT WAS CONCLUDED THAT THE PT'S FALL HAD DAMAGED THE PULSE GENERATOR SO A NEW (MODEL# 333) GENERATOR WAS CALLED FOR. THE ORIGINAL GENERATOR WAS DISCONNECTED AND THE LEAD CHARACTERISTICS RE-CHECKED. THE EVENT THAT OCCURRED WITH THE EXISTING LEAD AND PACEMAKER WAS REPORTED TO FDA (M2522457-1997-00013 AND M2522457-1997-00014). THE NEW PULSE GENERATOR WAS CONNECTED TO THE AT-443 LEAD AND INSERTED INTO THE POCKET. ATRIAL TRACKING WAS NOT OBSERVED. THE LEAD/PACER CONNECTION WAS AGAIN RE-CHECKED AS WERE THE LEAD CHARACTERISTICS. THERE WAS NO EVIDENCE OF DAMAGE OR LEAD DISPLACEMENT. THE PACER AND LEAD WERE RE-CONNECTED AND INSERTED INTO THE POCKET. AGAIN, NO ATRIAL TRACKING WAS OBSERVED. THE UNIT WAS PROGRAMMED TO VVI AND COMPLETE INHIBITION WAS OBSERVED. WHEN THE RATE WAS PROGRAMMED TO 90PPM NORMAL VENTRICULAR PACING WAS OBSERVED. THE PROCEDURE WAS COMPLETED AND PT RELEASED TO RECOVER. AT POST-OP CHECK-UP REPROGRAMMING TO VDD DID NOT RESULT IN OBSERVABLE P-R INTERVAL. AN ALL DATA PRINTOUT WAS OBTAINED AND CONFIRMED VDD PACING WAS PROGRAMMED WITH STANDARD BOL VALUES OF IMPEDANCE AND CELL VOLTAGES. UPON REVIEW OF INFO RECEIVED IT WAS CONCLUDED THAT THE IMPLANTED PACING LEAD WAS EXHIBITING SYMPTOMS CONSISTENT WITH INTERMITTENT SHORT CIRCUIT OF THE ATRIAL ELECTRODES. WHEN THE LEAD WAS EXPOSED AND TESTED BY THE PSA THE SHORT CIRCUIT WAS NOT APPARENT. WHEN THE LEAD WAS COILED AND PLACED IN THE POCKET THE SYMPTOMS OF THE SHORT BECAME MANIFEST. PHYSICIAN ELECTED TO PROGRAM THE PACEMAKER SYSTEM TO VVI MODE TO AVOID A THIRD SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSAFE ENDOCARDIAL PACING LEAD Implant PACING LEAD DTB CARDIAC CONTROL SYSTEMS, INC AT-443 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization