BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA SR

    MDR report key: 1875007 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05438
    Event Type
    Injury
    Date Received
    October 19, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS ANALYZED AND DID NOT MEET ITS EXPECTED LONGEVITY. THE CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSSIBLE PREMATURE BATTERY DEPLETION, BUT THAT DEVICE EXPERIENCED HIGH OUTPUT DUE TO INCREASED RV THRESHOLDS ON A COMPETITOR LEAD. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R (B)(4) COMPETITOR IMPLANTABLE PACING LEAD