BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1922678 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05969
    Event Type
    Injury
    Date Received
    December 13, 2010
    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
    TX, 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. EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED THAT BATTERY DEPLETION INDICATED WAS INDICATED. ERI: BATTERY VOLTAGE OF 2.18 V AND ERI TRIPPED ON (B)(4) 2010. ANALYSIS OF THE DEVICE CONFIRMED THE HIGH CURRENT DRAIN CONDITION WAS THE RESULT OF HIGH CURRENT LEAKAGE INTERNAL TO THE CERAMIC CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT THE ELECTIVE REPLACEMENT INDICATOR. WHEN THIS INDICATOR WAS RESET, THE IMPEDANCE READINGS ON BOTH LEADS WERE HIGH. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 5076 X2 IMPLANTABLE PACING LEAD