BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4092377 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17078
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 21, 2014
    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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS DEPLETING PREMATURELY FROM 75% FULL TO 25% OVER NIGHT, EVEN THOUGH THE INS WAS NOT BEING USED. IT WAS NOTED THAT THE INS WAS TILTED AND THEREFORE THERE WAS POOR COUPLING. THE PATIENT RARELY GOT 3 COUPLING BARS WHEN RECHARGING AND USUALLY ONLY GOT 1 OR 0 COUPLING BARS. THE PATIENT DID NOT SEE A POWER ON RESET (POR) ERROR. IT WAS ALSO REPORTED THAT ERROR CODES 375 AND 376 WERE SEEN ON THE RECHARGER. THE PATIENT STATUS WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. IT WAS STATED THAT THE PATIENT¿S LEAD NEEDED TO BE REVISED AND THE INS WAS NOT GOING TO BE REPLACED UNTIL THE LEAD REVISION TOOK PLACE, BUT IT WAS UNKNOWN WHEN THIS WOULD OCCUR. THE INS WAS TURNED OFF AT THE TIME OF REPORT. ANALYSIS OF THE RECHARGER FOUND A BROKEN WIRE INSIDE THE ANTENNA CABLE AND FOUND THE CHARGE CABLE ON THE ADAPTER WAS DAMAGED. THE ANTENNA ASSEMBLY AND CHARGE CABLE WERE REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED SCAR TISSUE HAD FORMED AROUND THE LEAD WHICH CAUSED SORENESS WHEN STIMULATION WAS TURNED ON. REVISION SURGERY HAD NOT BEEN SCHEDULED. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY BECAUSE THE PATIENT KEPT STIMULATION TURNED OFF DUE TO THE SORENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572824 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 Required Intervention