BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 5147116 · Received October 14, 2015

    Report

    Report Number
    3004209178-2015-20513
    Event Type
    Injury
    Date Received
    October 14, 2015
    Report Date
    September 23, 2015
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-39, LOT# N243315, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3 778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE DID NOT RECHARGE THE BATTERY FOR A WHILE AND THUS IT WENT INTO OVERDISCHARGE A MONTH AGO. THE PATIENT MET WITH A REPRESENTATIVE TO TRY AND REVIVE THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT IT COULDN'T BE DONE. THE PATIENT GOT A NEW IMPLANT AS A RESULT. THE PATIENT LATER NOTED THAT HE HAD AN APPOINTMENT TO SEE THE PATIENT IN (B)(6) BUT THE PATIENT CANCELLED IT BECAUSE SHE WASN'T FEELING WELL. THE REP SUSPECTED AN OVERDISCHARGE BUT THE PATIENT NEVER RE-SCHEDULED AN APPOINTMENT. THE PATIENT WAS ON THE SCHEDULE FOR REPLACEMENT IN (B)(6). THE REP LEARNED OF THAT A DAY OR TWO BEFORE THE PROCEDURE. THE OVERDISCHARGE WAS CONFIRMED ON THE DATE SHE WAS REPLACED BECAUSE THE DEVICE COULD NOT BE INTERROGATED PRE-PROCEDURE. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678052 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Required Intervention