BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2830982 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10218
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 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
    MG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (MODEL# 3778-60, SERIAL# (B)(4)) FOUND ALL CONDUCTOR WIRES BROKEN 19.9 CM FROM THE DISTAL END. THE ANCHOR SITE WAS 21 CM FROM THE DISTAL END. FUNCTIONAL TESTING REVEALED OPEN CIRCUITS ON ALL WIRES. ANALYSIS OF THE LEAD (MODEL# 3778-60, SERIAL# (B)(4)) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF PAIN RELIEF BILATERALLY IN THE LEGS AND LOWER BACK WITH STIMULATION IN THE WRONG LOCATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). HIGH IMPEDANCES (>20,000 OHMS) WERE MEASURED ON ELECTRODES # THRU 15 BUT WERE NORMAL ON THE OTHER LEAD. BOTH LEADS WERE THEN REPLACED. THE PATIENT WAS REPORTED AS DONG "GREAT" IN THE RECOVERY ROOM WITH EXCELLENT COVERAGE FOR THEIR PAIN NOTED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD TO WAIT 14 WEEKS FOR HIS REVISION SURGERY. THERE WAS ALSO A DISCREPANCY ON THE SURGERY DATE. IT WAS NOW REPORTED THAT IT OCCURRED ON (B)(6) 2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STIMULATION WENT OUT IN THE PRIOR YEAR AND IT TOOK 4 MONTHS FOR A REVISION. THE TIMEFRAME WAS UNCLEAR AS IT WAS PREVIOUSLY REPORTED AS 14 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00055 YR Required Intervention