BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2901982 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00315
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    August 16, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 309328, LOT# 0206327932, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: THE SETSCREW WAS BACKED OUT TOO FAR. NO SIGNIFICANT ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED DURING A SECONDARY STAGE, THE LEAD COULD NOT BE INSERTED INTO THE CONNECTOR OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE LEAD "REMAINED IN THE AREA OF THE SCREW HOOK AND WAS NOT ADVANCING." IT WAS STATED AN EXTENSION HAD TO BE IMPLANTED ALONG WITH A DIFFERENT INS. IT WAS FURTHER STATED THIS "WENT WITHOUT ANY PROBLEMS." IT WAS STATED THAT AN EXPLANT OR REVISION OCCURRED ON THE LEAD THE DAY OF THIS REPORT. IT WAS ALSO NOTED THE LEAD REMAINED IN THE PATIENT DUE TO THE "GREAT SUCCESS" OF THE THERAPY DURING TESTING. IT WAS ULTIMATELY UNCLEAR IF THE LEAD WAS EXPLANTED OR REVISED, AND IF THERE WAS MORE THAN ONE LEAD IN THE PATIENT. IT WAS INDICATED THERE WERE NO VISIBLE DEFORMATIONS ON THE LEAD. NO HARM OR INJURY WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10022 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1