BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2973748 · Received January 2, 2008

    Report

    Report Number
    3004209178-2008-09735
    Event Type
    Malfunction
    Date Received
    January 2, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 3, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REP REPORTED IN (B)(6) 2007, THE PT HAD NOT REC'D STIMULATION THERAPY FOR ONE OR TWO MONTHS; THE LAST SUCCESSFUL RECHARGE PERFORMED BY THE PT HAD BEEN IN (B)(6) 2007. AT FOLLOW-UP, THERE WAS NO TELEMETRY WITH THE PHYSICIAN OR PT PROGRAMMERS; THE INS WAS OVER-DISCHARGED FOR A SECOND TIME AND PT NON-COMPLIANCE WAS SUSPECTED. A PHYSICIAN MODE RECHARGE COULD NOT BE PERFORMED; THE PT RECHARGER WAS NOT AVAILABLE. THE REP WOULD FOLLOW-UP WITH THE PT. THE PT HAD ATTEMPTED THREE PHYSICIAN MODE RECHARGE SESSIONS AT HOME IN (B)(6) 2007. AT FOLLOW-UP IN (B)(6) 2007, THE REP REPORTED TELEMETRY ISSUES AND OVER-DISCHARGE OF THE INS. THERE HAD BEEN NO THERAPY BENEFIT FOR TWELVE MONTHS. ADD'L PHYSICIAN MODE RECHARGE ATTEMPTS WERE DEEMED REQUIRED DUE TO PT NON-COMPLIANCE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention IMPLANTED:| LEAD: MODEL 3777 LOT# N0039183| LEAD: MODEL 3777, LOT# N0032664| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB004566N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB004565N| IMPLANTED: