BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 7516646 · Received May 15, 2018

    Report

    Report Number
    3004209178-2018-10989
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Report Date
    May 15, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37761, SERIAL (B)(4), PRODUCT TYPE: RECHARGER. THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761, SERIAL/LOT (B)(4), ANALYSIS FOUND THE BOTTOM CASE OF THE DESKTOP CHARGER (SERIAL (B)(4)) WAS BADLY BROKEN, AND THE DEVICE WAS SCRAPPED. ALL FDM AND FDR CODES APPLY TO THE DESKTOP CHARGER (SERIAL (B)(4)). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT'S INS STOPPED WORKING. THE PATIENT FURTHER CLARIFIED STATING THEY COULD NOT CHARGE THE INS, BECAUSE THE RECHARGER (INSR) CORD WAS BROKEN. THE PATIENT STATED THE METAL TIP BROKE OFF THE CONNECTOR PIN; THEREFORE, THE INSR WOULD NOT CHARGE, AND THE PATIENT COULD NOT CHARGE THE INS. THE PATIENT STATED THE METAL TIP WAS STUCK FAR DOWN IN THE INSR, AND THE PATIENT WAS UNABLE TO REMOVE THE METAL TIP. THE PATIENT ADDED THAT THE AC POWER CORD WAS DAMAGED AND HAD EXPOSED WIRES. THE PATIENT ALSO REPORTED HER INSR BATTERY AND INS WERE DEPLETED. A REPLACEMENT RECHARGER AND DESKTOP CHARGER WERE SENT TO THE PATIENT. THE PATIENT REPORTED AT A LATER DATE THAT THE REPLACEMENT RECHARGER AND DESKTOP CHARGER WORKED VERY WELL AND RESOLVED THE INABILITY TO CHARGE AND DEPLETED INS. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358531 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1