BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4093445 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17117
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# V012101, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 377760, LOT# V012101, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE STIMULATOR STOPPED WORKING ABOUT SIX MONTHS PRIOR TO THE REPORT. THERE WAS A POOR COMMUNICATION SCREEN ON THE PATIENT PROGRAMMER. THE PATIENT TRIED REPLACING THE BATTERIES. WHILE THE PATIENT HAD A RECHARGEABLE DEVICE, HE DID NOT HAVE AN IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). THE LAST TIME THE PATIENT FELT STIMULATION WAS OVER SIX MONTHS AGO AND THE LAST SUCCESSFUL RECHARGE SESSION WAS UNKNOWN. LATER, THE PATIENT CALLED AND REPEATED THAT HE WAS UNABLE TO RECHARGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿NOT FUNCTIONING¿ AND ¿NOT WORKING AT ALL¿. IT WAS ALSO NOTED THAT THE STIMULATION SENSATION HAD STOPPED SUDDENLY ABOUT A MONTH AGO. THE PATIENT HAD NOT HAD THE INS DEVICE CHECKED AS THEIR MANAGING HEALTHCARE PROFESSIONAL (HCP) WAS 2 HOURS AWAY. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571054 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR