BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2364571 · Received December 9, 2011

    Report

    Report Number
    3004209178-2011-09694
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3093 LOT# V811041 IMPLANTED: (B)(6) 2011 EXPLANTED: (B)(6) 2011; LEAD MODEL 3093-28 LOT# V699314 IMPLANTED: (B)(6) 2011 EXPLANTED: NA; PROGRAMMER MODEL 3037 SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD MODEL 3093-28 FOUND NO ANOMALY. THE PROXIMAL END OF THE LEAD WAS OK. NO SETSCREW MARKS WERE OBSERVED. THE LEAD CONDUCTORS WERE OK AND THE OUTER INSULATION WAS INTACT. THE DISTAL END OF THE LEAD WAS OK. CONTINUITY WAS ACCEPTABLE AND THERE WERE NO SHORTS BETWEEN CIRCUITS.

    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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD WAS NEVER IMPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE MANUFACTURER REPRESENTATIVE COULD NOT GET ANY MOTOR OR SENSORY RESPONSE WITH THE LEAD HOOKED UP TO THE 3625 SCREENER BOX AND PATIENT TEST STIMULATION CABLES. THIS WAS DONE BILATERALLY WITH NO RESOLVE. ANOTHER LEAD WAS USED AND THE MOTOR/SENSORY RESPONSE WAS APPROPRIATE, AND THE FULL IMPLANT WAS COMPLETED. THE HCP STATED THAT HE THOUGHT THE PATIENT HAD A NEUROLOGICAL CONDITION THAT MAY HAVE CAUSED THE EVENT, BUT NO OTHER DETAILS WERE KNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE HAD NOT HEARD FROM THE PHYSICIAN ABOUT ANY ADDITIONAL PROBLEMS. THE REPRESENTATIVE WAS CONFIDENT THAT HE WOULD HAVE BEEN NOTIFIED IF THERE WAS A PROBLEM OR CONCERN, AND BELIEVED THAT THE PATIENT WAS DOING FINE WITH A NORMALLY FUNCTIONING INTERSTIM SYSTEM.

    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 00077 YR