BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 3190205 · Received June 21, 2013

    Report

    Report Number
    1000165971-2013-00309
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DURING A FOLLOW-UP VISIT ON (B)(6) 2013, FAILURE OF CAPTURE AND SEVERAL NOISE EPISODES WERE DETECTED. ONE OF THE NOISE EPISODES LED TO DELIVERY OF INAPPROPRIATE SHOCK. IT WAS ALSO INDICATED THAT THE ASSOCIATED PATIENT FILES FROM THIS DATE DID NOT HAVE STORED EGM EPISODES AND THERE WAS A MESSAGE INDICATING "UNABLE TO READ FILE". ALSO REPORTED: IMPEDANCE OF 901 OHMS, NO PACING AT 7 V - 1 MS. THE ASSOCIATED LEAD (ISOLINE 2CR, S/N (B)(4)) WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282330 PARADYM MRM SORIN GROUP ITALIA S.R.L PARADYM DR 8550 2512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention