BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3755538 · Received April 17, 2014

    Report

    Report Number
    3004209178-2014-07396
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Report Date
    March 28, 2014
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID" 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3 777-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3550-29, LOT# N130238, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS DEAD. IT WAS NOTED THAT FOR THAT PAST COUPLE WEEKS THAT PATIENT HAD BEEN RECHARGING EVERY DAY. IT WAS NOTED THAT 6 TO 7 DAYS AGO THE STIMULATION TURNED OFF (THE PATIENT NOTED THAT THEY CHARGED THE DAY PRIOR) AND THEY HAD BEEN UNABLE TO RECHARGE SINCE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE HEALTH CARE PROFESSIONAL (HCP) TODAY. IT WAS NOTED THAT THE HCP DID NOT CHECK THE DEVICE AND TOLD THE PATIENT TO CALL THE MANUFACTURER. IT WAS NOTED THAT THE PATIENT DID NOT RECALL SEEING A CALL YOUR DOCTOR OR ERROR MESSAGE ON THE PATIENT PROGRAMMER OR RECHARGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234989 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 00049 YR