BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2182317 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05282
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 RETURN OF PARALYSIS FROM HER HIP TO HER KNEE. ON (B)(6) 2011, THE SYMPTOMS CHANGED TO INCLUDE PARALYSIS FROM THE WAIST DOWN. THE PT WAS ALSO EXPERIENCING A PAINFUL STABBING SENSATION IN HER RIGHT LEG. THE SYMPTOMS OCCURRED AFTER THE PT SAT IN (B)(6) AT A RESTAURANT AND HER STIMULATION FELT TOO STRONG. THE PT USED HER HANDS TO "READJUST THE BATTERY" AND FELT HER IMPLANTABLE NEUROSTIMULATOR SHIFT AT THAT TIME. THE PT WAS IN THE EMERGENCY ROOM ON (B)(6) 2011. THE PT HAD BEEN TURNING THE DEVICE OFF AND ON. WITH THE DEVICE OFF, THE PT'S LEGS TREMBLED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT# 3004209178-2011-05236 FOR INFO REGARDING A PREVIOUS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR LEAD: MODEL 3093, LOT# V243044| PROGRAMMER: MODEL 3037, LOT# NJD081955N| EXTENSION: MODEL 3095, LOT# NAH036196V| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: