BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3190145 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10890
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 74001, LOT # N202799, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ADAPTER; PRODUCT ID 3550-29, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 7496, SERIAL # (B)(4), IMPLANTED: (B)(6) 1990, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3586, SERIAL # (B)(4), IMPLANTED: (B)(6) 1990, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 7496, SERIAL # (B)(4), IMPLANTED: (B)(6) 1990, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE ADAPTOR (LOT # N202799) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE OUTER INSULATION OF THE ADAPTOR BODY WAS MELTED. IT WAS SUSPECTED THAT THIS WAS A CAUTERY ARTIFACT. ANALYSIS OF THE ACCESSORY KIT FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION (SERIAL # (B)(4)) FOUND THAT THE OUTER INSULATION OF THE EXTENSION BODY HAD A BREACHED DEPRESSION. ANALYSIS OF THE LEAD (SERIAL # (B)(4)) FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THERE WERE SEVERAL BREACHED AND COSMETIC CUTS IN THE OUTER INSULATION. IT WAS SUSPECTED THAT THIS WAS EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LUMBAR SURGERY WITH REMOVAL OF THE SPINAL CORD STIMULATOR. THE DOCTOR REPORTEDLY NOTED THAT ¿IT WAS OLD.¿ IT WAS ALSO NOTED THAT THE REASON FOR REMOVAL WAS NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289534 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1