BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2369751 · Received December 13, 2011

    Report

    Report Number
    3004209178-2011-09743
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    November 15, 2011
    Report Date
    December 27, 2011
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 3023, SERIAL# (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. THE NEUROSTIMULATOR HAD NO TELEMETRY AND THERE WAS NO OUTPUT FROM ANY ELECTRODE PAIRS. END OF SERVICE WAS CALCULATED AT 14.61 MONTHS USING THE LOWEST PROGRAMMED SETTING. THE INS WAS CONSIDERED TO HAVE GONE THROUGH NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28, LOT #V141293, IMPLANTED: (B)(6) 2008; EXTENSION MODEL 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008; PROGRAMMER MODEL 3037, SERIAL # (B)(4). THE STIMULATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR WAS REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE PATIENT FELT THE BATTERY LIFE WAS LESS THAN EXPECTED DESPITE HAVING HIGH PROGRAMMING PARAMETERS FOR THE DEVICE. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention