BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2680136 · Received August 3, 2012

    Report

    Report Number
    3004209178-2012-06424
    Event Type
    Injury
    Date Received
    August 3, 2012
    Report Date
    July 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377875, LOT# V013537, SERIAL#, IMPLANTED: 2006 (B)(6), EXPLANTED: PRODUCT TYP LEAD, PRODUCT ID 377875, LOT# V013537, SERIAL#, IMPLANTED: 2006 (B)(6), EXPLANTED: PRODUCT TYP LEAD, PRODUCT ID 37752, LOT#, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: PRODUCT TYP RECHARGER, PRODUCT ID 37742, LOT#, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD OVERDISCHARGE CONDITIONS ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM IN THE PAST (NUMBER NOT KNOWN). THEIR INS SYSTEM NOW HAD A "DEAD" BATTERY AND AN END-OF-SERVICE (EOS)/END-OF-LIFE (EOL) MESSAGE WAS SEEN ON THE DEVICE SYSTEM. THE INS WAS SUBSEQUENTLY REPLACED WITH ANOTHER RECHARGEABLE INS MODEL. AFTER THE REPLACEMENT SURGERY, THE PATIENT WAS REPORTED AS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention