BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5006998 · Received August 17, 2015

    Report

    Report Number
    3004209178-2015-16107
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Report Date
    August 10, 2015
    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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377845, LOT# V013536, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377845, LOT# V013536, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE PATIENT DIED. WHEN ASKED IF IT WAS RELATED TO THE DEVICE OR THERAPY THE CONSUMER STATED YES BUT THEN STATED "NO IT WAS PNEUMONIA. SHE WENT TO THE HOSPITAL TO MAKE SURE THE DEVICE WAS WORKING BECAUSE IT LOST ITS' EFFECTIVENESS, AND TO SEE IF THERE WERE ANY OTHER MEDICATIONS SHE COULD HAVE."THE CONSUMER THEN STATED S AND NO, IT CERTAINLY WASN'T TO BLAME, BUT THE DEVICE WASN'T WORKING, AND SHE DIDN'T FEEL IT SINCE ABOUT A MONTH PRIOR," BUT THE DEVICE WAS NOT TO BLAME FOR THE PATIENT'S DEATH. RELEVANT MEDICAL HISTORY INCLUDES PERIPHERAL NEUROPATHY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE PATIENT DID NOT GO TO THE HOSPITAL FOR THEIR STIMULATOR; THEY WENT TO THE HOSPITAL BECAUSE OF THE PNEUMONIA. "THE STIMULATOR HAD NOTHING TO DO WITH HER PASSING." SHE HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED "YEARS AGO FOR LEG PAIN." SHE CHARGED IT PERIODICALLY AND THEN IT WORKED. IT JUST DIDN'T WORK AS WELL AS WHEN SHE FIRST HAD IT PUT IN. THE CONSUMER STATED IT WAS LIKE SHE GOT USED TO IT, SO IT DIDN'T HELP AS MUCH. THE INS HAD NOT BEEN CHECKED BY A MANUFACTURER'S REPRESENTATIVE (REP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542087 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1