BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 3991650 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14251
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A DAMAGED GROMMET. CONCOMITANT MEDICAL PRODUCTS: 507652 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT, AFTER THE DEVICE WAS ATTACHED TO THE LEADS, INTERMITTENT VENTRICULAR OVERSENSING WAS NOTED ON THE SURFACE ELECTROCARDIOGRAM. THE POCKET WAS RE-OPENED AND LEAD CONNECTIONS TESTED NORMAL. THE DEVICE WAS OBSERVED TO OVERSENSE AGAIN WHILE IN THE POCKET. THE VENTRICULAR LEAD WAS UNPLUGGED AND TESTED WITH THE ANALYZER WITH NO ABNORMALITIES OBSERVED. ONCE RE-ATTACHED TO THE DEVICE, OVERSENSING WAS AGAIN DETECTED. THE PHYSICIAN ELECTED TO USE ANOTHER DEVICE WHICH TESTED WITHIN NORMAL LIMITS. THE NEW DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471119 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC PUERTO RICO OPERATIONS CO. ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR 2088TC LEAD