BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2130511 · Received June 14, 2011

    Report

    Report Number
    3007566237-2011-04400
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 4, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRIMARY FINDING WAS HIGH BATTERY RESISTANCE. THE MOTOR STALLED DURING TORQUE SECTION OF THE CONSTANT LOAD TEST. RESIDUE WAS SEEN IN THE PINION OF GEAR TWO. THERE WERE NO SAFE STATES, ELECTIVE REPLACEMENT INDICATORS (ERI) OR RESETS NOTED DURING BENCH TESTING. THE PUMP ALARM WAS PROGRAMMED FOR A 2 TONE TEST WHERE THE DECIBEL LEVEL WAS MEASURED AND PASSED. VISUAL INSPECTION OF THE PUMP HEAD HOUSING COMPARTMENT REVEALED THERE WERE NO DROPS OF MOISTURE SEEN ON THE BOTTOM SIDE OF THE INNER COVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT GETTING GOOD PAIN RELIEF FOR (B)(6). MORPHINE/BUPIVACAIN WERE USED IN THE PUMP. THE PUMP WAS REMOVED PROPHYLACTICALLY TO AVOID BATTERY DEPLETION. ANALYSIS WAS REQUESTED BY THE HCP. "DYE/ROTOR STUDY WERE NEGATIVE." ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention CATHETER: MODEL 8731, LOT# N001790707| IMPLANTED:| EXPLANTED: