BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2013490 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00840
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 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
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PT WAS EXPERIENCING "MUSCLE SPASMS" FROM ABOUT "L4-5" TO HER "SHOULDERS" DURING THE FIRST EPISODE AND SPASM IN HER NECK DURING THE SECOND EPISODE. IT WAS NOTED THAT 2 WEEKS POST-OPERATIVELY, THE PT PICKED UP HER (B)(6) SON OFF THE FLOOR. THE SPASMS BEGAN AT 4 WEEKS POST-OPERATIVELY. THE PT UNDERWENT A CT SCAN WHICH REVEALED THE LEADS NEAR THE SACRAL NERVE. PER THE REPORTER, THE PT'S PRIMARY CARE PROVIDER BELIEVED THE STIMULATOR WAS CAUSING THE SPASMS; THE PRIMARY CARE PROVIDER BELIEVED THE LEAD "MAY BE OUT OF PLACE". PER THE REPORTER, THE IMPLANTING HEALTH CARE PROFESSIONAL BELIEVED THE SYSTEM WAS NOT CAUSING THE ISSUE. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD118792N| LEAD: MODEL 3093, LOT# V596314