BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2517213 · Received April 4, 2012

    Report

    Report Number
    3004209178-2012-02104
    Event Type
    Injury
    Date Received
    April 4, 2012
    Report Date
    March 13, 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 3888-45, LOT# V780541, IMPLANTED: 2012 (B)(6), EXPLANTED: NA. LEAD: MODEL 3888-45, LOT# V836553, IMPLANTED: 2012 (B)(6), EXPLANTED: NA. LEAD: MODEL 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: NA. PROGRAMMER: MODEL 37754, LOT# SERIAL# (B)(4). EXTENSION: MODEL 3708220, LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THE PATIENT HAD REVISION SURGERY WHERE THE LEAD WAS REPLACED. THE PATIENT WAS REPORTED AS RECEIVING EXCELLENT STIMULATION AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS TURNING OFF TWO WEEKS AFTER IMPLANTATION. A PHYSICIAN PROGRAMMER WAS USED DURING A REPROGRAMMING SESSION AND WHEN THE PATIENT REPORTED LOSS OF STIMULATION SENSATION, THE PROGRAMMER SHOWED THAT STIMULATION WAS STILL ON. ELECTRODES 0 AND 2 WERE SHORTED TOGETHER AND IMPEDANCES MEASURED LESS THAN 50 OHMS. IT WAS UNKNOWN IF THE SHORT MAY HAVE CAUSED THE LOSS OF STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT WAS "GOOD" AND HAD EXCELLENT COVERAGE OF HER PAIN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention