BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCRA CRT-P

    MDR report key: 3192889 · Received June 27, 2013

    Report

    Report Number
    9614453-2013-01459
    Event Type
    Death
    Date Received
    June 27, 2013
    Date of Event
    September 21, 2011
    Report Date
    July 29, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(6) 2013. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A BIMONTHLY MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON (B)(4) 2013. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2013 AND REVEALED THE PATIENT IS DECEASED. AS THERE IS NEW INFORMATION THAT REASONABLY SUGGESTS THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS EVENT NO LONGER QUALIFIES FOR BIMONTHLY REPORTING AND IS THEREFORE, BEING SUBMITTED AS A 30-DAY REPORT. CONCOMITANT PRODUCT: 419478 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2011. A 5076-58 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2002. A 5076-52 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2002. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FREQUENT PERIODS OF A MISSING VENTRICULAR PACE WERE NOTED ON A REMOTE TRANSMISSION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY FOUR MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292849 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death