BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2181414 · Received July 21, 2011

    Report

    Report Number
    3007566237-2011-05642
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    February 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 0592-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE PUMP REPORTED S2 CORROSION OR S2 CORROSION WITH MECHANICAL WEAR. RESIDUE AND WEAR WERE SEEN ON THE UPPER SHAFT OF GEAR TWO. RESIDUE WAS SEEN IN THE UPPER BRIDGE JEWEL FOR GEAR TWO. RESIDUE WAS SEEN ON BOTH THE UPPER AND LOWER SHAFTS OF THE ROTOR MAGNET. RESIDUE WAS ALSO SEEN IN THE UPPER AND LOWER BRIDGE JEWELS OF THE ROTOR MAGNET. RESIDUE WAS ALSO SEEN ON BOTH THE M1 AND THE M2 FEEDTHRUS. AFTER BEING EXPOSED TO ATMOSPHERE, AND ISOLATED FROM MOTOR THE M1 RESISTANCE WENT TO >10 MEG (18 MEG) AND THE M2 RESISTANCE WENT TO >10.

    Description of Event or Problem · 1

    ON (B)(6) 2011 IT WAS INITIALLY REPORTED THAT THE PUMP MOTOR STALLED MRI ON (B)(6) 2011. ON (B)(6) 2011 THE PATIENT FELT SICK AND VISITED THE PHYSICIAN ON (B)(6) 2011. THE PATIENT DID NOT HEAR THE ALARM AT HOME. ON INTERROGATION THE PHYSICIAN FOUND THAT THE MOTOR WAS STALLED AND THEN RECOVERED. THE PUMP WAS REPLACED FOR PROLONGED MOTOR STALL AND PROPHYLACTICALLY TO AVOID INVIVO BATTERY DEPLETION. IT WAS LATER REPORTED ON (B)(6) 2011 THAT THE MOTOR HAD STALLED FOR ABOUT AN HOUR. THE PATIENT HAD NO SIGNS AND SYMPTOMS. THE PUMP WAS USED TO DELIVER DILAUDID 10 MG/ML AT 2.165 MG/DAY. PATIENT WAS NOT HOSPITALIZED AND RECOVERED WITHOUT SEQUELAE.

    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 56 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8731, LOT# N001400733| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# B011786N18| IMPLANTED: