BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2864996 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11455
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 451253 IMPLANTABLE PACING LEAD 1988 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION WITH A HIGH CURRENT DRAIN ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD HAD LOW IMPEDANCE AND HIGH THRESHOLDS. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION WITH A HIGH CURRENT DRAIN ON THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD HAD LOW IMPEDANCE AND HIGH THRESHOLDS. THE DEVICE AND LEAD WERE 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 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC ADDR03

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R 5024M PACING LEAD