BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2791761 · Received October 15, 2012

    Report

    Report Number
    3004209178-2012-09208
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    September 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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 MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS UNABLE TO CHARGE THEIR IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT ON (B)(6) 2012, HER HEALTH CARE PROFESSIONAL (HCP) FOUND THAT THE DEVICE WAS FLIPPED VIA FLUOROSCOPY. THE PATIENT FELL APPROXIMATELY 5 DAYS LATER. THE PATIENT FELL FORWARD AND THE FALL "SHOULD NOT HAVE AFFECTED THE DEVICE." APPROXIMATELY 6 DAYS AFTER THE FALL WAS THE LAST TIME THE PATIENT WAS ABLE TO FEEL STIMULATION. THE NEXT DAY IT WAS REPORTED THAT THE INS BATTERY WAS "DEAD." IT WAS ALSO REPORTED THAT THE DEVICE WAS TURNED CLOCKWISE AND AT AN ANGLE, BUT WAS STILL FLAT. THAT SAME DAY IT WAS REPORTED THAT THE PATIENT TRIED TO RECHARGE THE INS BUT WAS NOT SUCCESSFUL. THE PATIENT STATED "IT WORKED GOOD FOR THE FIRST 2 WEEKS", THEN SHE HAD TO GET A NEW INS RECHARGER, AND "IT HAS BEEN A HASSLE EVER SINCE." THE PATIENT WAS "NOT HAPPY WITH THE RECHARGEABLE DEVICE" WAS GOING TO TALK WITH HER HCP ABOUT NON-RECHARGEABLE INS DEVICES. FOUR DAYS LATER IT WAS REPORTED THAT THE HCP PLANNED TO REPOSITION THE INS WITHIN THE POCKET. THE PATIENT STATED THAT SHE WOULD RATHER HAVE A NON-RECHARGEABLE DEVICE IMPLANTED. AT THIS TIME THE PATIENT REPORTED THAT AFTER HER SURGERY IN MAY SHE HAD MORE PAIN THAN EXPECTED WHERE THE LEADS ENTER HER SPINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1