BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2061979 · Received April 6, 2011

    Report

    Report Number
    3004209178-2011-02654
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT WAS CHARGING MORE THAN EXPECTED. THERE WERE COUPLING/COMMUNICATION ISSUES. SHE HAD BEEN CHARGING VERY FREQUENTLY SINCE HER DEVICE OVERDISCHARGED. IT WAS LASTER REPORTED THAT A TRICKLE CHARGE WAS COMPLETED AND HER STIMULATION WAS FUNCTIONING. THE PT WAS CHARGING TWICE A DAY COMPARED TO ONCE EVERY 3 WEEKS. THE BATTERY DROPPED FROM COMPLETELY CHARGED TO 50% IN LESS THAN 30 MINUTES. A DIFFERENT RECHARGER WAS GOING TO BE TRIED SINCE HERS IS OVER 5 YEARS OLD. THE RECHARGE INTERVAL DID NOT APPEAR APPROPRIATED. PER HER PROGRAM, THE DEVICE SHOULD BE RECHARGED ON AVERAGE OF EVERY 23-50 DAYS. THE STATS ON THE 8840 TYPICAL DURATION WAS 0.4 AND FREQUENCY INTERVAL OF 0.5. THE BATTERY WAS DEPLETING EXTREMELY RAPIDLY. THE PLAN WAS TO REPLACE THE INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD022925N| LEAD: MODEL 3778, LOT# V104569003| LEAD: MODEL 3778, LOT# V104569002| ACCESSORY: MODEL 37752, LOT# NKA019169N