BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1022591 · Received April 1, 2008

    Report

    Report Number
    3004209178-2008-01697
    Event Type
    Injury
    Date Received
    April 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT REPORTED IN LATE 2007, THAT SYMPTOMS OF BLEEDING HAD BEEN DETECTED TWO MONTHS EARLIER FROM THE PULSE GENERATOR INCISION SITE. THE HCP WAS CONTACTED BY THE PT AT THAT TIME AND CYST FORMATION HAD BEEN SUSPECTED. THE PT REPORTED NEW PAIN AT THE INCISION SITE, IT HAD BEEN SORE "AT THE BOTTOM" WHERE A SCAB HAD FORMED. THERE WAS NO CHANGE TO STIMULATION THERAPY, BUT A PHYSICAL SENSATION WAS DETECTED WHEN THE PT SAT DOWN. THE HCP REPORTED THAT THE PT HAD DEVELOPED A POST-OPERATIVE WOUND INFECTION, WHICH HAD CAUSED THE PULSE GENERATOR TO COME THROUGH (ERODE), FROM THE POCKET LOCATED IN THE LEFT BUTTOCK AREA. NO OTHER PT SYMPTOMS WERE REPORTED. THE EVENT HAD NOT BEEN ATTRIBUTED TO IMPLANTED PROD AND THE SYS WAS REMOVED. THE PT'S PROGNOSIS HAD BEEN GUARDED; HE WAS STILL RECOVERING. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3777 LOT# V006641| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD MODEL 3777 LOT# V006641