BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1870471 · Received October 11, 2010

    Report

    Report Number
    3004209178-2010-07799
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 13, 2010
    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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 06/16/2010 THAT THE PT HAD PHYSICAL DIFFICULTIES AND WAS UNABLE TO CHARGE HER PULSE GENERATOR AND THERE WAS AN INABILITY TO INTERROGATE. THE BATTERY WAS OVERDISCHARGED. THE DEVICE WAS RECHARGED. THERE WERE NO PT SYMPTOMS. THE FOLLOWING TESTS WERE RUN: X-RAY, IMPEDANCE MEASUREMENT AND REPROGRAMMING. THE BATTERY COULD NOT BE RECHARGED AFTER MULTIPLE ATTEMPTS. REPEATED "JUMP START" ATTEMPTS AT RECHARGING HAD BEEN UNSUCCESSFUL. THE SYSTEM WAS REPLACED ON (B)(4) 2010. THE OUTCOME WAS: RESOLVED WITHOUT SEQUELAE.

    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 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL # 3487A, LOT # V009230| PROGRAMMER: MODEL 37742, LOT # NJD027716N| EXPLANTED:| LEAD: MODEL # 3487A, LOT # V009230| IMPLANTED:| EXTENSION: MODEL 37082, LOT # NKB003118N| EXPLANTED:| EXTENSION: MODEL 37082, LOT # NKB003119N| ACCESSORY: MODEL 37752, LOT # NKA020601N| EXPLANTED:| IMPLANTED: