BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1120745 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04967
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE HEALTH PROFESSIONAL WAS UNABLE TO READ NEUROSTIMULATOR. INTERROGATION LOGS FROM ONE OF THE STIMULATORS FOUR MONTHS BEFORE HAD SHOWN THE DEVICE USE AT 16%, PROGRAMMED AT A CONTINUOUS MODE WITH UPPER LIMITS OF 10.5 V AMPLITUDE AND 450 US PULSE WIDTH FOR PROGRAMS 1 AND 2. THE BATTERY WAS OK AT THAT TIME, WITH 3.06 V. THE LOG SHOWED IMPEDANCES FOR THREE PAIRS AT 500 OHMS AND 17 UA; ALL OTHER 25 PAIRS SHOWED IMPEDANCE AT 761 OHMS AND <15 UA (OUT OF RANGE CURRENT). ACCORDING TO THE DEVICE REGISTRATION SYSTEM, THE EXTENSIONS ON ONE OF THE SYSTEMS HAD BEEN REPLACED IN 2008. IT WAS NOT POSSIBLE FOR THE HEALTH PROFESSIONAL TO DETERMINE IF BATTERY DEPLETION WAS NORMAL. BOTH DEVICES WERE REPLACED. NO SYMPTOMS OR OUTCOME WERE REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. PLEASE SEE MFR REPORT #3004209178-2008-04966.

    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 68 YR Required Intervention EXTENSION MODEL 7489| EXPLANTED| EXPLANTED| EXTENSION MODEL 7489| EXPLANTED| LEAD MODEL 3487A| EXPLANTED| EXPLANTED| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 7435| EXTENSION MODEL 7489| IMPLANTABLE NEURO STIMULATOR MODEL 7427V| LOT #NFE409431H| LEAD MODEL 3487A| LEAD MODEL 3888| LEAD MODEL 3888| EXPLANTED| EXPLANTED| EXTENSION MODEL 7489