BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2565345 · Received May 9, 2012

    Report

    Report Number
    3004209178-2012-03111
    Event Type
    Injury
    Date Received
    May 9, 2012
    Report Date
    April 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3998 LOT# V013862 IMPLANTED: (B)(6) 2007 EXPLANTED: UNK; LEAD MODEL 3776-60 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: UNK; RECHARGER MODEL 37752 SERIAL# (B)(4); PROGRAMMER MODEL 37742 SERIAL# (B)(4); EXTENSION MODEL 3708260 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD COUPLING/COMMUNICATION ISSUES BETWEEN THEIR EXTERNAL RECHARGER AND THE IMPLANTABLE NEUROSTIMULATOR (INS). AN OVERDISCHARGE OF THE BATTERY WAS SUSPECTED AND PATIENT COMPLIANCE WITH RECHARGING WAS REPORTED AS THE REASON. THE LAST TIME THE PATIENT FELT THEIR STIMULATION WAS OVER 12 MONTHS AGO. FOLLOW UP INFORMATION REPORTED THAT THE PATIENT HAD NEVER HAD THERAPEUTIC EFFECT SINCE IMPLANT OF THE INS SYSTEM EVEN AFTER 10 PLUS "UNSUCCESSFUL" REPROGRAMMING SESSIONS OVER THE YEARS. SHE DESIRED TO HAVE THE INS REMOVED SINCE IT NEVER COVERED HER PAIN. THE REMOVAL OF THE INS HAD NOT BEEN SCHEDULE AT THE TIME OF THIS REPORT. 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 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention