BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 2684777 · Received August 7, 2012

    Report

    Report Number
    9614453-2012-00115
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Report Date
    July 9, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING ID ORIGINALLY REPORTED AS (B)(4). ADDITIONAL REVIEW INDICATES CORRECT MANUFACTURING ID IS (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE LEAD REVEALED A SHORT BETWEEN CIRCUITS 1 AND 3 ON THE PROXIMAL END OF THE CONDUCTOR. IT WAS NOTED THAT ON THE #3 CONDUCTOR, THE OUTER CONDUCTOR INSULATION WAS ABRADED. FINAL ANALYSIS OF THE STYLET REVEALED BREACHED PARYLENE COATING. IT WAS NOTED THAT THE STYLET WIRE WAS BENT AT THE DISTAL END. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT# V931137) FOUND THERE WAS A CONDUCTOR CROSSOVER AT THE PROXIMAL END.

    Additional Manufacturer Narrative · 1

    THERE WAS ANOTHER ANALYSIS OF THE LEAD AND STYLET. IN ADDITION TO THE PREVIOUS ANALYSIS OF THE LEAD THERE WAS A FURTHER PROCEDURAL NON-CONFORMANCE. THE PROXIMAL END CONDUCT HAD A SHORT BETWEEN CIRCUITS. IT WAS NOTED THAT THERE WERE DRY CONDITIONS. IT WAS ALSO NOTED THAT A CROSSOVER WAS OBSERVED WITH AN X-RAY AND CONFIRMED WHEN DESTRUCTIVE ANALYSIS WAS PERFORMED. THERE WAS ALSO VISIBLE DEPTH STOP DAMAGE. ANALYSIS OF THE STYLET ACCESSORY FOUND THAT THERE WAS A PROCEDURAL NON-CONFORMANCE. IT WAS NOTED THAT THE WIRE PARYLENE COATING WAS DAMAGED AT THE DEPTH STOP SITE. IT WAS NOTED THAT THERE WAS VISIBLE DEPTH STOP DAMAGE ON THE STYLET.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_STYLET_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3387S-40, LOT# V931137, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE LEAD. DURING THE IMPLANT PROCEDURE, AN INTRAOPERATIVE IMPEDANCE TEST WAS DONE AND FOUND THERE WAS A SHORT ON 1 AND 3 WITH AN IMPEDANCE OF 86 OHMS. THE PHYSICIAN WAS USING A LONG STYLET THAT WAS PACKAGED WITH THE LEAD AND THE TWISTLOCK SCREENING CABLE. IT WAS ATTEMPTED TO UNTWIST AND RECONNECT SCREENING CABLE WITH NO RESOLVE. ANOTHER LEAD WAS USED, EVERYTHING CHECKED OUT FINE, AND THE PATIENT WAS DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1