BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2469585 · Received February 27, 2012

    Report

    Report Number
    3004209178-2012-01208
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28 LOT# V872900 IMPLANTED: (B)(6) 2012 EXPLANTED: NA; PROGRAMMER MODEL 3037 SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3889-28, LOT# V872900, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEURO STIMULATOR MODEL 3058, SERIAL NUMBER (B)(4), INDICATED THAT NO ANOMALY WAS FOUND. THE LEAD MODEL 3889-28, LOT NUMBER V872900, WAS ANALYZED AND WAS FOUND TO HAVE NO SIGNIFICANT ANOMALIES. THERE WAS NO OUTPUT ON # 0 CIRCUIT AND THE CONNECTOR WAS CRUSHED AT THE PROXIMAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FROM A STAGE ONE IMPLANT WAS USED FOR A PERMANENT IMPLANT PROCEDURE. THE PATIENT WAS PROGRAMMED TO 0+3- DURING THE STAGE ONE IMPLANT WITH NO ISSUES AND INTRA-OPERATIVE IMPEDANCES DID NOT SHOW A SHORT CIRCUIT. POST-OPERATIVE IMPEDANCES SHOWED LESS THAN 50 OHMS ON ELECTRODE PAIR 0+3-. ALL OTHER COMBINATION PAIRS WERE REPORTED AS IN NORMAL RANGE. THE PATIENT WAS REPROGRAMMED AROUND TO 0+2- AND THIS YIELDED A STIMULATION SENSATION IN THE TAILBONE AREA. THE PATIENT SCHEDULED AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER TO FURTHER INVESTIGATE THE ISSUE. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW-UP INFORMATION REPORTED INDICATED THAT THE PATIENT HAD THEIR ENTIRE SYSTEM REPLACED ON (B)(6) 2012. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE STAGE ONE TRIAL WORKED GREAT. WHEN THEY TRIED TO IMPLANT THE NEUROSTIMULATOR FOR STAGE TWO, "IT STOPPED WORKING." IT WAS NOTED THAT THE PATIENT COULD NO LONGER FEEL STIMULATION, PRIOR TO REMOVAL OF THE SYSTEM. THERE WAS NO DEATH OR INJURY TO THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THAT PATIENT STILL HAD TROUBLE FEELING THE STIMULATION FROM OF THE IMPLANTABLE NEUROSTIMULATOR (INS), EVEN WHEN IT WAS TURNED UP TO 8.5 VOLTS. THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6), 2012. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention