BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2628410 · Received June 26, 2012

    Report

    Report Number
    3004209178-2012-04854
    Event Type
    Injury
    Date Received
    June 26, 2012
    Report Date
    May 24, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    P970004, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID HAVE A LEAD REPLACEMENT ON (B)(6) 2012 WITH A NEW LEAD (MODEL #: 3093-28, LOT #: V867752). THE PATIENT HAD FELL ON HER PORCH AND INDICATED THAT SHE WAS "GETTING SHOCKED" POST-FALL. AFTER SEVERAL REPROGRAMMING SESSIONS, THE PATIENT CONTINUED TO EXPERIENCE POOR RESULTS AND A SHOCKING SENSATION, SO THE PATIENT AND HER PHYSICIAN DECIDED TO REPLACE THE LEAD. POST REVISION, THE PATIENT RETURNED TO GOOD RESULTS AND NO LONGER EXPERIENCED THE SHOCKING SENSATION. THE LEAD WAS DISPOSED OF POST-REVISION AND WAS NOT AVAILABLE FOR ANALYSIS. IT WAS NOTED THAT THERE WAS "IMPEDANCE VISUALIZED" WITH INTERROGATION ON THE ORIGINAL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING IN THE RECTUM. THE INFORMATION WAS INITIALLY REPORTED UNDER MFR # 3004209178- 2012-04778, BUT WAS LATER DETERMINED TO BE A SEPARATE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention