BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8666056 · Received June 4, 2019

    Report

    Report Number
    3004209178-2019-10798
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    November 7, 2016
    Report Date
    July 25, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V931559, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 31-JAN-2016. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V931559, IMPLANTED: (B)(6) 2012, EXPLANTED: (B )(6) 2016. PRODUCT TYPE LEAD. EVAL CODE METHOD, EVAL CODE-RESULT, AND EVAL CODE-CONCLUSION APPLY TO INTERSTIM II (SERIAL#(B )(4)) AND LEAD (LOT#V931559). ANALYSIS: ANALYSIS OF THE IPG 3058 INTERSTIM LL (SERIAL#(B)(4)) FOUND NO ANOMALIES; THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED ALL TESTING IN THE LABORATORY. ANALYSIS: ANALYSIS OF THE TINED LEAD, 3889-28, INTERSTIM,US 28 CM (LOT#V931559) FOUND CONTINUITY WAS COMPLETE AND THERE WERE NO ELECTRICAL SHORTS BETWEEN THE CIRCUITS EVEN THOUGH THE LEAD WAS RETURNED SEGMENTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. AN INS AND LEAD WERE RETURNED TO THE MANUFACTURING COMPANY AS ¿NON-FUNCTIONING¿. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460307 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention