BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1791529 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03082
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    December 22, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    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) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL SIDE OF THE DEVICE WOULD NOT SENSE OR PACE ONE DAY POST-IMPLANT. THE POST-IMPLANT NUMBER HAD BEEN PERFECT. PRIOR TO REPLACEMENT, ATRIAL UNIPOLAR MODE WAS TRIED TO SEE IF APPROPRIATE BEHAVIOR WOULD RESULT, BUT IT DID NOT. 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 DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 5076 (X2) IMPLANTABLE PACING LEADS