BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRA CRT-P

    MDR report key: 2203378 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01420
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 20, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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): THE DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PHYSICIAN HAD DIFFICULTIES SCREWING IN THE SETSCREW. THE SCREWDRIVER DID NOT SEEM TO MAKE CONTACT TO ENABLE THE SETSCREW TO SCREW IN AND THE PHYSICIAN FELT THERE WAS A PROBLEM WITH THE PORT. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRA CRT-P IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. C2TR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other