BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3000378 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-03606
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 25, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V172549, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3093-33, LOT# V172549, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BOTH OF THEIR SYSTEMS REMOVED BECAUSE THE STIMULATION THERAPY NEVER WORKED FOR THE PATIENT. DURING EXPLANT THE SURGEON LEFT A PIECE OF WIRE IN THE PATIENT WHICH WAS 'ROUGHLY AN INCH LONG' LOCATED NEAR THE S3 NERVE CONNECTION TO THE SPINAL CORD. NO FURTHER INFORMATION ABOUT THE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103927 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention