BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD

    MDR report key: 3063508 · Received April 17, 2013

    Report

    Report Number
    3007566237-2013-01324
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-67, SERIAL# UNKNOWN. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID NEU_ UNKNOWN_EXT, SERIAL# UNKNOWN. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S HEALTH CARE PROVIDER ¿PRESUMED TIGHTENING OF THE PROTECTIVE BOOT ONTO THE LEAD AT LEAD IMPLANTATION¿ HAD CAUSED THE EVENT. IT WAS NOTED NO SURGICAL INTERVENTION HAD OCCURRED. IT WAS FURTHER NOTED THE PATIENT HAD NO INJURIES AND RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED AT STAGE II IMPLANT IMPEDANCE MEASUREMENTS WITH CONTACT 11 WERE GREATER THAN 40,000 OHMS. THERE WAS NO VISUAL DAMAGE TO THE LEAD. THE EXTENSION WAS REPLACED WITH NO CHANGE IN IMPEDANCE MEASUREMENTS. THE LEAD END CAP WAS USED. IT WAS LATER REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WERE UNKNOWN. THE PATIENT WENT ON TO IMPLANT BUT THE INS HAS NOT BEEN TURNED ON YET. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164741 LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1