BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4010130 · Received August 14, 2014

    Report

    Report Number
    3004209178-2014-15321
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V833270, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS OF THE LEAD MODEL 3093-33 LOT #V833270 SHOWED THAT CONDUCTORS #0, 1, AND 3 WERE BROKEN 6.2 CM (AT OR NEAR THE TINES) FROM THE DISTAL END. CIRCUITS #0, 1, AND, 3 WERE FOUND TO BE OPEN. SHORT CIRCUITS WERE ALSO SEEN BETWEEN #2 AND 3 CIRCUITS DUE TO OVERSTRESS DAMAGE (SUSPECTED) AT THE DISTAL SIDE OF THE BREAK. THE CONDUCTORS WERE STRETCHED AND THE COILS WERE CRUSHED. THE OUTER INSULATION WAS BROKEN WITH SUSPECTED TOOL MARKS.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE IMPEDANCE ISSUE OCCURRED IN (B)(6) 2014 AND THE HIGH IMPEDANCES WAS RESOLVED AFTER REPLACEMENT. THE CAUSE OF IMPEDANCE WAS NOT DETERMINED. IT WAS INDICATED THAT THE LEAD FRACTURED WHILE BEING EXPLANTED. NO OTHER DEVICE ABNORMALITIES WERE OBSERVED WITH EXPLANTED DEVICE. IT WAS NOTED THAT IMPEDANCE TESTING WAS CONDUCTED AT MULTIPLE AMPLITUDES AND MULTIPLE PULSE WIDTHS AT THE CLINIC DURING THE WEEK PRIOR TO EXPLANT AND REPLACEMENT. IMPEDANCES >4,000 WERE OBSERVED ON ALL ELECTRODE PAIR COMBINATIONS EXCEPT C <(>&<)> 2, C <(>&<)>3, AND 2 <(>&<)> 3. PATIENT FELT NO STIMULATION AT 8.5 VOLTS WHEN STIMULATING ANY ELECTRODE COMBINATION EXCEPT FOR C + <(>&<)> 2-3- WHICH CAUSED A SHOCKING SENSATION. IT WAS NOTED THAT PATIENT RETURNED TO EFFICACY AND TOLERABILITY WITH THE THERAPY SINCE THE REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES OF >4000 OHMS ON ELECTRODE PAIR COMBINATIONS #0 AND 10 WERE OBSERVED ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). THE LEAD COMPONENT WAS THEN REPLACED ALONG WITH THE INS BATTERY WHICH HAD DEPLETED NORMALLY. NO PATIENT INJURIES WERE REPORTED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485257 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR