BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2181447 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05109
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT ABLE TO MAKE ADJUSTMENTS BOTH WITH OR WITHOUT ANTENNA ATTACHED. IT WAS REPORTED COUPLING AND OR COMMUNICATION ISSUES. REVIEWED HOW POCKET SIZE, DEPTH, AND LOCATION CAN IMPACT COUPLING. RECOMMENDED PALPATING INS POCKET TO ASSESS DEPTH AND POSITION OF INS. IT WAS REPORTED THAT NO STIMULATION SENSATION OCCURRED FOLLOWING A FALL. PT FALLS "ALL THE TIME." ADD'L 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA033657N| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD053254N| LEAD: MODEL 3777, LOT# V055174028| IMPLANTED: