BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8083192 · Received November 19, 2018

    Report

    Report Number
    3004209178-2018-25677
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    December 1, 2008
    Report Date
    January 16, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT#: V072260, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 10-DEC-2011, UDI#:(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. PATIENT REPORTED HE NOTICED ONE WEEK AGO THAT THE LEAD IN HIS BACK WAS COMING OUTSIDE OF SKIN ON BACK. PATIENT STATED THAT HIS IMPLANT QUIT WORKING ABOUT 6 MONTHS AFTER IMPLANT, SOMETIME IN 2008. PATIENT STATED THAT HE THINKS A LEAD CAME LOOSE BECAUSE HIS WIFE SAID SHE SAW A LEAD ABOUT TO POP OUT OF HIS SKIN. IT WENT AWAY EVENTUALLY. PATIENT STATED THEY SAW THE IMPLANT AND ONE LEAD, AND THEY SAID EVERYTHING LOOKED FINE. PATIENT STATED HE WAS TOLD BY HCP THAT THERE WERE TWO LEADS GOING TO TWO DIFFERENT PLACES, SO HE WAS WONDERING WHERE THE OTHER LEAD IS. PATIENT SERVICES REVIEWED THERE WAS ONLY ONE LEAD REGISTERED, BUT PATIENT DID NOT THINK THAT HE WAS RIGHT, SO PATIENT SERVICES DIRECTED PATIENT TO CONTACT IMPLANTING PHYSICIAN FOR IMPLANT RECORDS. THE PATIENT LATER STATED IT STARTED TO POKE THROUGH. HE SAID HE STILL GOT IT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    PATIENT RESPONDED TO A LETTER. THE PATIENT DIDN'T KNOW WHEN ASKED WHAT WERE THE CIRCUMSTANCES THAT LED TO THE IMPLANT QUIT WORKING. THEY ADDED THAT IT SHOULD WORK, BUT THEN IT QUIT AND THEN THE WIRE POKED THROUGH THE SKIN. THE HEALTHCARE PROVIDER (HCP) IS NOT RETURNING THE PATIENT'S CALLS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924627 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR