BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2592098 · Received May 30, 2012

    Report

    Report Number
    3004209178-2012-03815
    Event Type
    Injury
    Date Received
    May 30, 2012
    Report Date
    May 2, 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

    LEAD MODEL 3777, LOT# V345322023, IMPLANTED: 2009-(B)(6), EXPLANTED: 2012-(B)(6), RECHARGER MODEL 37752, SERIAL# (B)(4), PROGRAMMER MODEL 37743, SERIAL# (B)(4), ANCHOR MODEL 3550-39, LOT# N202828, IMPLANTED: 2009-(B)(6), EXPLANTED: 2012-(B)(6), ADAPTOR ACCESSORY MODEL 3550-29, LOT# N179704, IMPLANTED: 2009-(B)(6), EXPLANTED: NA. (B)(4). ANALYSIS OF LEAD MODEL 3778, LOT # V345322023 SHOWED NO SIGNIFICANT ANOMALIES. ANALYSIS OF ANCHOR MODEL 3550-38, LOT #N202828 SHOWED THAT THE SILICONE PORTION OF THE ANCHOR WAS BROKEN/TORN IN 2 PIECES AND HALF OF THE BROKEN SILICONE SLEEVE WAS SEPARATED FROM THE INSERT. THE SILICONE CUT WAS IN A DIFFERENT AREA FROM THE TEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) IN THE WRONG LOCATION FOLLOWING A FALL IN (B)(6) 2011. IT WAS NOTED THAT THE PATIENT HAD STIMULATION ON THEIR LEFT SIDE AND THAT THE INS ONLY WORKED ON THEIR RIGHT SIDE. HIGH IMPEDANCES (>10,000 OHMS) WERE ALSO MEASURED ON ALL ELECTRODE COMBINATIONS EXCEPT #5 <(>&<)> 6 AND #5 <(>&<)> 7. ON (B)(6), 2012, A REVISION PROCEDURE WAS PERFORMED AT WHICH TIME THE LEAD WAS REPLACED. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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