BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3070552 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01374
    Event Type
    Death
    Date Received
    April 22, 2013
    Date of Event
    February 26, 2007
    Report Date
    September 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A STIMULATION SYSTEM PUT IN AT (B)(6). IT WAS STATED THAT A YEAR LATER, THE PATIENT FELL AND "IT KILLED HIM BECAUSE HE RUPTURED HIS SKULL". FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD PASSED AWAY 5 YEARS AGO AFTER FALLING IN HIS GARAGE AND FRACTURING HIS SKULL. IT WAS STATED THAT THIS WAS "MAYBE 6 MONTHS AFTER THE DEVICE WAS IMPLANTED". FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD BEEN WALKING UP THE STAIRS FROM THE BASEMENT CARRYING A BAG OF GROCERIES WHEN HE FELL BACKWARD AND FRACTURED HIS SKULL ON THE CONCRETE FLOOR BELOW. HE DID NOT RECOVER FROM THE HEAD INJURY. IT WAS STATED "THE DEVICE HAD NOTHING TO DO WITH THE FALL" AND THAT HE MISSED A STAIR AND WASN'T HOLDING ONTO THE RAILING. THE DEVICE WAS LEFT IN HIM FOR BURIAL. THE DATE OF DEATH WAS (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171658 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1