BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR MRI

    MDR report key: 3931338 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12942
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    July 7, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A MONTH AFTER HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED ((B)(6) 2014) SHE HAD TROUBLE CONNECTING AND GETTING THE INS TO CHARGE. IT REPORTEDLY ¿QUIT ON HER.¿ IT WAS NOTED THE PATIENT WAS NOT FEELING STIMULATION AND THE BATTERY WAS NOT LOW ¿AT THE TIME.¿ IT WAS REPORTED THE PATIENT WAS IN THE PHYSICIAN¿S OFFICE AND MET WITH A MANUFACTURER REPRESENTATIVE (REP). THE REP¿S DEVICE WOULDN¿T CONNECT. AT THAT TIME THE PATIENT¿S HUSBAND GOT SICK AND SHE WAS UNABLE TO RECHARGE FOR A COUPLE MONTHS. THE PATIENT HAD AN APPOINTMENT WITH HER HEALTH CARE PROVIDER (HCP) TOMORROW. IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. PROBLEMS WITH RECHARGE COUPLING AND PATIENT COMPLIANCE WERE THE PRIMARY REASONS FOR OVERDISCHARGE. THE PATIENT EXPERIENCED NO STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT. ADDITIONAL INFORMATION RECEIVED REPORTED INS HAD ITS FIRST CONFIRMED OVERDISCHARGE. A PHYSICIAN MODE RECHARGE (PMR) WAS NOT PERFORMED. THE ANTENNA LOCATOR WAS USED TO FIND THE BEST SPOT FOR THE RECHARGER AND RECHARGING OF THE BATTERY WAS INITIATED. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD BEEN PERFORMED BUT WOULD BE IN THE FUTURE. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF AND PAIN ON THE RIGHT SIDE OF THE IMPLANT. THE PATIENT HAD NOT CHARGED HER DEVICE IN A WHILE AND HAD SOME DIFFICULTY GETTING CORRECT STIMULATION IN THE PAST. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY ADDITIONAL INFORMATION RECEIVED REPORTED THE REP SAW THE PATIENT LATER IN THE DAY AND THE POWER ON RESET (POR) WAS RESET AND THE PATIENT WAS SUCCESSFULLY REPROGRAMMED. THE PATIENT WAS DOING WELL WITH GOOD RELIEF AND WOULD CALL THE REP IF SHE NEEDED ANYTHING ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409134 RESTORE SENSOR MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR