BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2101718 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03437
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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 INITIALLY REPORTED THAT INS OVERDISCHARGE OCCURRED IN THE PAST MONTH, NOT CERTAIN OF THE NUMBER OF TIMES. MULTIPLE OVERDISCHARGE PROTOCOLS INITIATED WITH TWO DIFFERENT RECHARGERS. NOT SUCCESSFUL IN PMR (PHYSICIAN MODE RECHARGE) PROTOCOL DUE TO TELEMETRY ISSUES. F/U REPORTING NOTED THAT THE PT WAS INTERROGATED WITH TWO PROGRAMMERS, A PT PROGRAMMER AND TRIED TO COMMUNICATE WITH TWO SEPARATE RECHARGERS. THEY WERE UNABLE TO GET ANYTHING TO COMMUNICATE OR RESET. THE PT HAD HISTORICALLY HAD ISSUES WITH RECHARGING, AND HAD BEEN SHOWN TO RECHARGE SEVERAL TIMES, INCLUDING 1-2 PORS (POWER ON RESETS). THE FOLLOWING PHYSICIAN HAD SENT THE PT TO THE SURGEON FOR F/U FOR INCREASED PAIN AND WITH A RECOMMENDATION FOR A NONRECHARGEABLE GENERATOR REPLACEMENT. THE SURGEON SENT THE PT TO A NEUROLOGIST FOR EVAL FOR PROGRESSION OF HIS PERIPHERAL NEUROPATHY PRIOR TO STIMULATOR CHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR STIM ACCESSORY: MODEL 3550-29, LOT# N057230| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# J0211582V| EXTENSION: MODEL 37083, LOT# NKC005337N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# J0211582V| EXTENSION: MODEL 37083, LOT# NKC005338N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA015409N| EXPLANTED: