BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1230635 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07268
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS OF THE PT PROGRAMMER REVEALED NO ANOMALY FOUND, THE PT'S COMPLAINT COULD NOT BE VERIFIED. ONLY THE PT PROGRAMMER WAS RETURNED, THE STIMULATOR SYSTEM REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED DIFFICULTY BREATHING AT NIGHT BEGINNING APPROX 3 WEEKS AFTER THE STIMULATOR SYSTEM WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING THE REMOVAL OF THE BANDAGES, WHICH WAS PAINFUL,THE PT BEGAN EXPERIENCING SPELLS OF DIFFICULTY BREATHING BOTH DURING THE DAY AND AT NIGHT. THE PT ALSO EXPERIENCED "JITTERS" WHICH MADE IT DIFFICULT TO WRITE/TYPE. THREE DAYS AFTER THE PT BEGAN EXPERIENCING "JITTERS," IT WAS NOTED THAT THE PT WAS UNABLE TO OBTAIN TELEMETRY WITH EITHER ANTENNAS. THE PT PROGRAMMER WAS RETURNED TO THE MFR, ANALYZED, AND RETURNED TO THE PT. NO PT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFO 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 ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE115079N| LEAD: MODEL 3487A, LOT # V137284| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT # V152812| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT # NKB014515N| RECHARGER: MODEL 37752, LOT # NKA117765N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT # V152812| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT # V137284| EXTENSION: MODEL 37082, LOT # NKB014214N