BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3498294 · Received December 3, 2013

    Report

    Report Number
    3004209178-2013-21865
    Event Type
    Injury
    Date Received
    December 3, 2013
    Report Date
    November 18, 2013
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT USED THEIR DEVICE FOR 3-4 WEEKS AND IT WENT INTO OVERDISCHARGE (OD). THE PATIENT HAD A PREVIOUS OD A YEAR AGO, BUT IT WAS SUSPECTED THAT THIS WAS THE THIRD STRIKE/THIRD OD AS THE DEVICE WAS AT END OF SERVICE (EOS). IT WAS ADVISED THAT THE DEVICE BE REPLACED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO 3 OVERDISCHARGES OF THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT NO ABNORMAL IMPEDANCES WERE MEASURED. IT WAS FURTHER NOTED THAT THE PATIENT DID NOT CHARGE THE BATTERY ROUTINELY. IT WAS NOTED THAT THE INS WAS REPROGRAMMED ON (B)(6) 2013. IT WAS NOTED THAT THE BATTERY WAS INTERROGATED AND DETERMINED TO BE IN AN OVERDISCHARGE STATE. IT WAS NOTED THAT A SURGICAL REPLACEMENT OCCURRED ON (B)(6) 2013. THE PATIENT WAS NOT HOSPITALIZED DUE TO THIS EVENT. IT WAS NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S BATTERY WAS REPLACED ON "(B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626622 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention