BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA SR

    MDR report key: 1891584 · Received November 5, 2010

    Report

    Report Number
    2647346-2010-00719
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    May 24, 2010
    Report Date
    September 18, 2019
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND, DISTAL CONDUCTOR STRETCHED, OUTER INSULATION COSMETIC CUT AND ESC AND DEPRESSION. APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #002 SHOULD HAVE BEEN SEQUENCED #001, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICLE LEAD WAS OVER SENSING. THE LEAD REMAINS ACTIVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THE PATIENT DIED APPROXIMATELY 4 MONTHS LATER WITH CAUSE OF DEATH NOTED TO BE "ACUTE CVA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA SR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL, INC. ADSR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death ADSR01 - IMPLANTABLE PULSE GENERATOR| ADSR01 - IMPLANTABLE PULSE GENERATOR