BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2081332 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02987
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 1, 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 EXPERIENCED A SURGING SENSATION THAT WAS GOING ON FOR A FEW MONTHS. THE PT MET WITH THE MFR'S REP FOR REPROGRAMMING A WEEK AGO. ONE OF THE LEADS WASN'T WORKING AND THEY WERE PROGRAMMING AROUND IT. THE PT WAS NOW HAVING SHOCKING JOLTING SENSATION IN HER ARMS AND HANDS AND VERY LITTLE STIMULATION IN HER NECK. IF THE PT TURNED HER NECK A CERTAIN WAY THE "STIM BOLTS REALLY HARD." THE STIM WAS TURNED OFF. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. THE PT WAS AT HOME AT THE TIME OF THE REPORT. ADD'L INFO HAS BEEN REQUESTED.

    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 53 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V023021006| EXTENSION: MODEL 37081, LOT# NJB007006N| EXTENSION: MODEL 37081, LOT# NJB007005N| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V023021005| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD038595N