BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3150298 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08726
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO CORRECT CONCLUSION CODES.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS 37714 RESTORE, SERIAL # (B)(4)) FOUND ITS BATTERY HAD A REDUCED CAPACITY DUE TO OVERDISCHARGE. ACCORDING TO THE TRACE REPORT, THE INS WAS RECHARGED ONLY ONCE ((B)(6) 2011, 6 DAYS AFTER IMPLANT) BEFORE BEING RECEIVED FOR ANALYSIS. NO OTHER RECHARGE SESSION WAS PERFORMED DURING THE DURATION OF THE IMPLANT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN OVERDISCHARGE WAS SUSPECTED DUE TO PATIENT NON-COMPLIANCE. IT WAS NOTED THE DEVICE WAS EXPLANTED ON THE DAY OF RE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251323 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 Required Intervention