BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 8046546 · Received November 7, 2018

    Report

    Report Number
    3007566237-2018-03248
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7496, SERIAL# (B)(4), IMPLANTED: (B)(6) 1990, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 7496, SERIAL/LOT #: (B)(4), UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT PATIENT HAD UNRELATED HEART BYPASS SURGERY AND THE SURGEON CUT THROUGH THE WIRES IN THE PATIENT'S CHEST. THE CALLER THEN ASKED LEAD INFORMATION AND WHAT MATERIAL THEY WERE MADE OUT OF. IT WAS RECOMMENDED FOR THE HEALTH CARE PROFESSIONAL (HCP) TO CALL IN AND ASK SPECIFIC DEVICE -RELATED QUESTIONS TO BEST ANSWER INQUIRY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE PATIENT'S DBS "WIRES HAD BEEN CUT." "THE PATIENT HAD HEART SURGERY AND THE WIRES WERE CUT AS A RESULT" THE CALLER WAS AWARE THE PATIENT HAD 2 DBS SYSTEMS. THERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885351 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7424

    Patients

    Seq Age Sex Outcome Treatment
    1