BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2884471 · Received December 22, 2012

    Report

    Report Number
    3004209178-2012-12196
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 3, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986A, LOT# N124005, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST (B)(6) POUNDS AND THE IMPLANT IN HIS CHEST APPEARED TO BE "BULGING" OUT OF HIS BODY AND CAUSING HIM PAIN. THE IMPLANT WAS NOT FUNCTIONAL DUE TO THE LAST TIME IT WAS CHARGED WAS THREE YEARS AGO. THE PATIENT WANTED THE IMPLANT REMOVED BECAUSE IT NEVER WORKED FOR THE PAIN AREA HE NEEDED IT TO COVER. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE RELATED MANUFACTURING REPORT #3007566237-2012-03094 FOR RELATED EVENT. THE PATIENT HAD INFECTIONS AND THE DEVICE POCKET WAS MOVED.

    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