BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8070675 · Received November 14, 2018

    Report

    Report Number
    3004209178-2018-25434
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    August 13, 2018
    Report Date
    November 30, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATE. 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 HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. THE PATIENT REPORTED A LOSS OF SYMPTOM RELIEF. IT WAS REPORTED THAT THE PATIENT FELL IN (B)(6) 2018, BUT THEIR SYMPTOMS WERE FINE UNTIL AFTER THEY HAD AN MRI 3 MONTHS PRIOR. THE IMPEDANCES WERE TESTED AND THE FOLLOWING IMPEDANCE RESULTS WERE REPORTED: C0 1742 OHMS C1 645 C2 871 C3 1072 01 1051 02 1322 03 1771 12 1172 13 1501 23 1771OHMS 3-0+ PROGRAM 4.6 VOLTS THERAPY MEASUREMENT 1302 OHMS 46-89% 15-29 MONTHS THE HEALTHCARE PROVIDER WAS GOING TO REPROGRAM THE DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. [OMITTED INFORMATION FROM (B)(4): POOR COMM WITH PATIENT PROGRAMMER]

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THEY WERE NOT ABLE TO REPROGRAM HIS INS AS HIS PATIENT PROGRAMMER WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912019 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR