BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1130968 · Received August 21, 2008

    Report

    Report Number
    3004209178-2008-05149
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE LEAD REVEALED A RELIABILITY NON-CONFORMANCE - BROKEN CONDUCTORS IN BODY OF LEAD (ANCHOR SITE UNKNOWN). CONDUCTORS #2 AND #3 WERE BROKEN 12.05 CM FROM THE DISTAL END. THE #0 CONDUCTOR WAS BROKEN AT THE CONNECTOR SLEEVE WELD.

    Description of Event or Problem · 1

    A COUPLE OF MONTHS PRIOR TO THE LEAD BEING REPLACED, THE PATIENT STARTED GOING BACK TO THE GYM AND NOTICED THAT HIS STIMULATION HAD STOPPED. DURING THE REPLACEMENT SURGERY, IT WAS NOTED THAT THE LEAD WAS BROKEN AND DISLODGED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention EXPLANTED:| UNKNOWN CONVERSION TYPE MODEL 3550-09 LOT# N055973| IMPLANTED:| PROGRAMMER MODEL 7435 LOT# NFT016794P| EXPLANTED:| IMPLANTED:| LEAD MODEL 3487A LOT# J0005644V| EXPLANTED:| EXTENSION MODEL 7495-66 LOT# XS0006777N| IMPLANTED:| IMPLANTED:| EXPLANTED: