BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADYM

    MDR report key: 1735967 · Received June 23, 2010

    Report

    Report Number
    1000165971-2010-00766
    Event Type
    Death
    Date Received
    June 23, 2010
    Date of Event
    April 28, 2010
    Report Date
    June 10, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, PT WAS FOUND DEAD AT HOME AND HAD BEEN DEAD FOR SEVERAL DAYS. THE ICD INVOLVED IN THIS MDR REPORT WAS INTERROGATED AT MORTUARY ON 4TH MAY 2010: MORTICIAN COMMENTED THAT THE LEAD APPEARED TO BE FLOATING IN THE VENTRICLE. FILES SHOWED VT/VF STORM FROM 08:24, THE LAST VF EPISODE ON (B) (6), 4 MAX ENERGY SHOCKS DELIVERED, LAST SHOCK APPEARS UNSUCCESSFUL, EGM LOOKS LIKE VERY SMALL AMPLITUDE VF UNSENSED BY THE DEVICE. AV CONDUCTION EGM SEEMS TO SHOW VENTRICULAR CAPTURE ON THE VEGM RECORDED ON (B) (6), HOWEVER ON 1ST MAY THERE SEEMS TO BE NO CAPTURE ON THE VEGM. LEAD IMPEDANCE SHOWED SUDDEN INCREASE IN BOTH A AND V LEAD, HOWEVER UNABLE TO DETERMINE THE EXACT DATE OF THE SUDDEN INCREASE IN IMPEDANCE. SHOCK LEAD INTEGRITY SHOWED SUDDEN INCREASE ON (B) (6). THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE PHYSICIAN WANTED TO KNOW IF IT IS POSSIBLE TO FIND THE EXACT DATE OF THE SUDDEN INCREASE IN IMPEDANCE ON ALL LEADS AND COULD THIS SUDDEN INCREASE BE CAUSED AS A RESULT OF THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN BIOMEDICA C.R.M., S.R.L. PARADYM DR 8550 2376

    Patients

    Seq Age Sex Outcome Treatment
    1 Death