BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8150114 · Received December 11, 2018

    Report

    Report Number
    3004209178-2018-27339
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    December 8, 2009
    Report Date
    December 11, 2018
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-28, LOT# V360690, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 12-NOV-2013, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. IT WAS REPORTED THAT THE PATIENT SAID THE DEVICE DIDN'T WORK AND ACTUALLY HADN'T WORKED SINCE THEY GOT IT, THEY EXPERIENCED NO THERA PEUTIC BENEFIT. PATIENT REPORTED THEY HAD A FOLLOW-UP APPOINTMENT AND THEY SAID THAT ONE OF THE WIRES WASN'T WORKING, WIRE #5. THE PATIENT SAID THEY ALSO HAD ONE REPROGRAMMING SESSION WITH A MANUFACTURER REPRESENTATIVE. PATIENT REPORTED INTERMITTENT DISCOMFORT AT THE INS SITE AND SOMETIMES IT REALLY HURT AND SEEMED LIKE IT WAS MORE PUFFED. PATIENT REPORTED THEY WANTED TO HAVE THE INS REMOVED. CALLER WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991950 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR