BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2160941 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-04498
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 19, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED A "VERY SIGNIFICANT" JOLT WHILE AT WORK IN AN ENVIRONMENT CONTAINING A SIGNIFICANT AMOUNT OF ELECTROMAGNETIC INTERFERENCE (EMI). THE PT TURNED THE STIMULATION OFF FOR THREE TO FIVE DAYS. AFTER THIS TIME, THE PT WAS UNABLE TO TURN THE STIMULATION BACK ON. FORTY TO FORTY-FIVE DAYS FOLLOWING THE EVENT, IT WAS NOT POSSIBLE TO RESTART THE BATTERY VIA FOUR PHYSICIAN MODE RECHARGES (PMR'S). IT WAS LATER REPORTED THAT RECHARGE STATISTICS INDICATED THAT THE PT'S DEVICE HAD NOT BEEN CHARGED SINCE AUGUST 2010. AN OVERDISCHARGE OF THE PT'S DEVICE WAS SUSPECTED. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADDITIONAL INFO WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR LEAD: MODEL 3778, LOT# V075300019| IMPLANTED:| LEAD: MODEL 3778, LOT# V075300020| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE103538N| EXPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752, LOT# NKA111114N