BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2241567 · Received September 9, 2011

    Report

    Report Number
    2182863-2011-00080
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 10, 2011
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011.THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4), 2011.THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    AFTER 1+ YEARS OF IMPLANTATION, THIS DEVICE WAS EXPLANTED BECAUSE OF NO PACING OR CAPTURE AND THERE WERE HIGH IMPEDANCE READINGS. DURING THE EXPLANTATION, IT WAS REPORTED THAT THE ST. JUDE LEAD WAS FOUND PULLED OUT OF THIS ICD HEADER, THE LEAD WAS RECONNECTED HOWEVER THE PHYSICIAN DECIDED TO REPLACE THE ICD SINCE IT WAS UNCERTAIN IF THERE WAS A SETSCREW ISSUE. A NEW PARADYM WAS IMPLANTED.

    Description of Event or Problem · 1

    AFTER 1+ YEARS OF IMPLANTATION, THIS DEVICE WAS EXPLANTED BECAUSE OF NO PACING OR CAPTURE AND THERE WERE HIGH IMPEDANCE READINGS. DURING THE EXPLANTATION, IT WAS REPORTED THAT THE ST. JUDE LEAD WAS FOUND PULLED OUT OF THIS ICD HEADER, THE LEAD WAS RECONNECTED HOWEVER THE PHYSICIAN DECIDED TO REPLACE THE ICD SINCE IT WAS UNCERTAIN IF THERE WAS A SETSCREW ISSUE. A NEW PARADYM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK SORIN BIOMEDICA CRM S.R.L. 8750

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR