BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5298257 · Received December 15, 2015

    Report

    Report Number
    3004209178-2015-25062
    Event Type
    Injury
    Date Received
    December 15, 2015
    Date of Event
    January 1, 2012
    Report Date
    November 17, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRECISE EXPLANT DATE OF THE DEVICE REMAINS UNCLEAR, HOWEVER THE PATIENT REPORTED THE SYSTEM WAS ULTIMATELY EXPLANTED SOME TIME IN 2013, AFTER THE PRESENTLY REPORTED EVENT. CONCOMITANT PRODUCT: PRODUCT ID: 3093-33, LOT# V833270, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT STATED THERAPY WAS NOT HELPFUL. THE PATIENT CLAIMED IT DID NOT WORK AND IT REQUIRED A POCKET REVISION.

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE THERAPY INDICATION "GASTROINTESTINAL/ PELVIC FLOOR" REPORTED THAT THEIR LEAD AND INS WERE MOVED TO THE OTHER SIDE OF THEIR BODY IN 2012. INFORMATION REGARDING THE ALLEGED ISSUE, EVENT CONTEXT, SYMPTOMS, DIAGNOSTICS/TROUBLESHOOTING, POTENTIAL CAUSES, OR OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828582 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Required Intervention