BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1171212 · Received September 22, 2008

    Report

    Report Number
    3004209178-2008-05988
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD A CSF LEAK. THE SYMPTOMS REPORTED WERE SEVERE HEADACHES, LIGHT AND SOUND SENSITIVITY, NAUSEA, VERTIGO, PULSATING AND THROBBING PAIN. THE HCP TOLD THE PT "IT WAS A SPINAL HEADACHE AND WOULD HEAL IN A WEEK OR SO". THE PT HAS SEEN MULTIPLE PHYSICIANS, UNDERGONE MULTIPLE TESTS - CT SCANS, MYELOGRAMS, STERNOGRAMS, AS WELL AS VARIUS MEDICATION WITHOUT RELIEF FOR HIS PAIN. THE PT STATED "IT [THE PAIN] IS CONSTANT AND UNBEARABLE" - "I WOULD TAKE MY OWN LIFE IF IT WASN'T AGAINST MY RELIGION". ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3776 LOT# V040915004| EXPLANTED| IMPLANTED| LEAD MODEL 3776 LOT# V040915005| IMPLANTED| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD045981N| IMPLANTED| ACCESSORY MODEL 37752 LOT# NKA034576N| EXPLANTED| EXPLANTED