BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2250637 · Received September 13, 2011

    Report

    Report Number
    3004209178-2011-07818
    Event Type
    Injury
    Date Received
    September 13, 2011
    Report Date
    August 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, LEADING TO A LOSS OF BLADDER CONTROL. THE PATIENT HAD AN EPILEPTIC SEIZURE IN (B)(6) 2010 AND FELL ON A TILE FLOOR. THE STIMULATION STOPPED WORKING. THE HCP WANTED TO PERFORM AN MRI TO DETERMINE THE CAUSE OF THE BLADDER NOT WORKING. IT WAS REPORTED THAT THE PATIENT HAD ALREADY HAD TWO MRIS, ONE IN (B)(6) 2011 AND ONE IN (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT HAD SIX INFECTIONS IN (B)(6). IT WAS ALSO REPORTED THAT THE LOOP RECORDER AND PAIN STIMULATOR HAD BEEN REMOVED (SEE MFR REPORT #3004209178-2011-07479). ADDITIONAL INFORMATION 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 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| LEAD: MODEL 3093, LOT# V222578| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH042713V| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD084981N