BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3132184 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08254
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 2, 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 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING TELEMETRY ISSUES. IT WAS NOTED THAT THE PATIENT HAD A SUSPECTED OVERDISCHARGE. IT WAS NOTED THAT A PHYSICIAN MODE RESTART (PMR) OR ANTENNA LOCATE (AL) WOULD NOT BE PERFORMED. IT WAS NOTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WOULD BE REPLACED BECAUSE THE PATIENT WAS SCHEDULED FOR A LEAD REVISION SURGERY. IT WAS NOTED THAT THE PATIENT¿S LEAD REVISION SURGERY WAS SCHEDULED DUE TO A LACK OF COVERAGE IN THE BACK. IT WAS NOTED THAT THE PATIENT DID NOT HAVE STIMULATION COVERAGE IN THE BACK SINCE THE LEAD WAS ORIGINALLY PLACED. IT WAS UNKNOWN IF THIS ISSUE WAS DUE TO AN IMPEDANCE ISSUE. IT WAS UNKNOWN WHEN THE OVERDISCHARGE OCCURRED BECAUSE THE PATIENT HAD NOT BEEN USING THE INS DUE TO A LACK OF COVERAGE AND WAS NOT RECHARGING EITHER. IT WAS FURTHER NOTED THAT THE PATIENT MET WITH A MANUFACTURING REPRESENTATIVE THE WEEK PRIOR TO THE REPORT, BUT THE REPORTER WAS UNSURE IF AN AL WAS PERFORMED. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013. IT WAS NOTED THAT THE ¿LEAD LEVEL WAS NOT GETTING THE PATIENT¿S BACK.¿ IT WAS FURTHER NOTED THAT THE PHYSICIAN PUT IN A NEW LEAD ¿AS IT WAS ACCIDENTALLY CUT IN SURGERY.¿ IT WAS NOTED THAT THE PATIENT WAS GETTING ¿GOOD¿ COVERAGE IN HIS BACK INTRA-OPERATIVELY AND IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235040 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 00068 YR Required Intervention