BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1861166 · Received October 4, 2010

    Report

    Report Number
    3004209178-2010-07585
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 8, 2010
    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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION FROM HER DEVICE. THE PT STATED THE SENSATION "GOES DOWN HER LEG AND THROUGH THE BOTTOM OF HER FOOT - OCCURS WHETHER THERAPY IS ON OR OFF." THE PT ALSO REPORTED RIB STIMULATION THAT STARTED "A FEW WEEKS AGO." THE CALL ALSO REPORTED THEY BELIEVE THAT THEIR DEVICE HAD "MOVED QUITE A BIT AND THERE IS A SHARP EDGE." THE PT STATED SHE "HAS BEEN MORE ACTIVE THAN SHE PERHAPS SHOULD BE." ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 30 YR IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA037612N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V118939008| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V086181| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE113756N| IMPLANTED:| LEAD: MODEL 3487A, LOT# V136340| EXTENSION: MODEL 37082, LOT# NKB011684N