BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1844818 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07220
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    October 6, 2009
    Report Date
    January 7, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V278328, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. DUE TO IMDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. EVAL (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED PT HAD NO STIMULATION SENSATION. PT'S DAUGHTER STATED NURSE TOLD HER THAT ONLY 1 ELECTRODE WAS WORKING. IT WAS NOTED PT HAD BEEN TO HCP SEVERAL TIMES IN THE LAST COUPLE OF WEEKS WITH RETURN OF SYMPTOMS. PT WAS TO MEET WITH HCP AND HAVE IMPLANT CHECKED. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A FAMILY MEMBER WHO SAID THERAPY NEVER WORKED FROM THE BEGINNING AND WISHES THAT THE PATIENT NEVER RECEIVED THE DEVICE. THE CALLER ADDED THAT THE PATIENT DID HAVE REPROGRAMMING SESSIONS. THEY NOTED THAT THE PATIENT HASN'T USED THE DEVICE AND BELIEVES STIMULATION WAS TURNED OFF AT THAT TIMES. CALLER SAID THE PATIENT HAS MOVED SEVERAL TIMES AND DOESN'T BELIEVE THEY EVENT HAVE A PATIENT PROGRAMMER (PP) ANYMORE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR LEAD: MODEL 3093, LOT# V278328| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD092414N| EXPLANTED:| EXPLANTED:| IMPLANTED: