BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2701031 · Received August 15, 2012

    Report

    Report Number
    3004209178-2012-06933
    Event Type
    Injury
    Date Received
    August 15, 2012
    Report Date
    July 19, 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

    (B)(4). LEAD: MODEL 39565-30 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: NA; EXTENSION: MODEL 3708140, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: NA; EXTENSION: MODEL 3708140, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: NA; PROGRAMMER: MODEL 37742, SERIAL# (B)(4); RECHARGER: MODEL 37752, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TELEMETRY ISSUES AND AN INS OVERDISCHARGE WAS SUSPECTED. THE PATIENT HAD STOPPED USING HIS STIMULATOR AND HAD NOT RECHARGED IN OVER A YEAR DUE TO MASSIVE SWINGS IN THE INTENSITY OF THE STIMULATION WITH POSTURAL CHANGES. IN ADDITION, IT WAS REPORTED THAT THE PATIENT HAD NEVER GOTTEN THERAPEUTIC EFFECT. SEVERAL PHYSICIAN RECHARGE MODES WERE PERFORMED AND THE PATIENT WAS ABLE TO OBTAIN A NORMAL CHARGING SCREEN. THE PATIENT CHARGED THE BATTERY, WENT SIX DAYS WITHOUT CHARGING, AND THE BATTERY WAS AGAIN UNABLE TO COMMUNICATE WITH THE 8840 PROGRAMMER DUE TO DISCHARGE. IT WAS NOTED THAT THE PATIENT HAD LOST A LOT OF WEIGHT. A POWER-ON-RESET CONDITION WAS REPORTED. IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING HIS BATTERY REPLACED WITH A RESTORESENSOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS DOING "WONDERFULLY" POST-PROCEDURE. STIMULATOR WAS EXPLANTED ALONG WITH THE EXTENSIONS AND PREVIOUS FUSION HARDWARE. PREVIOUS FUSION HARDWARE HAD FAILED AND DOCTOR REPEATED THE FUSION PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT ANTICIPATE NEEDING HIS STIMULATOR AGAIN. THE PADDLE LEAD WAS KEPT IN PLACE JUST IN CASE THE PATIENT SHOULD DESIRE SPINAL CORD STIMULATION AGAIN IN THE FUTURE.

    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 Required Intervention