BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3063499 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06437
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V109244, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Additional Manufacturer Narrative · 1

    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

    ANALYSIS OF NEUROSTIMULATOR MODEL 3058, SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. ANALYSIS OF LEAD MODEL 3889-28 LOT # V109244 SHOWED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION ((B)(6) 2010). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WOULD NEED TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED FOR AN MRI. IT WAS STATED, THE PATIENT WAS GETTING "GOOD THERAPY" AND THAT "EVERYTHING WORKS FINE AND THEY DID NOT WANT TO MESS WITH IT." ABOUT TWO WEEKS LATER IT WAS REPORTED THE SYSTEM WAS REMOVED BECAUSE, THE PATIENT NEEDED A FULL BODY MRI. DURING THE LEAD REMOVAL, IT WAS NOTED, THE LEAD FRACTURED "JUST BELOW THE FIRST TINE." IT WAS INDICATED THE "COMPLETE WIRE" WAS REMOVED FROM THE PATIENT, BUT THE "ELECTRODES REMAINED IN THE PATIENT." IT WAS ADDED THAT THERE WAS A "NORMAL" ESTIMATED REPLACEMENT INDICATOR REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) CONFIRMED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS EXPLANTED BECAUSE THE PATIENT NEEDED AN MRI. IT WAS ALSO NOTED THAT ¿RE-IMPLANTATION¿ WAS SCHEDULED. NO OTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE BATTERY DEPLETED NORMALLY. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164738 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Other| R