BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM RF CRT

    MDR report key: 3485798 · Received November 25, 2013

    Report

    Report Number
    2182863-2013-00079
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRELIMINARY ANALYSIS FROM THE MANUFACTURER WAS RECEIVED ON (B)(4) 2013 STATING THAT THE DEVICE MAY REMAIN IMPLANTED, MORE DETAILS WILL BE PROVIDED LATER. A SUBSEQUENT ANALYSIS FROM THE MANUFACTURER IS PENDING.

    Additional Manufacturer Narrative · 1

    (B)(6) 2013- A PRELIMINARY ANALYSIS FROM THE MANUFACTURER WAS RECEIVED ON (B)(6) 2013 STATING THAT THE DEVICE MAY REMAIN IMPLANTED, MORE DETAILS WILL BE PROVIDED LATER. A SUBSEQUENT ANALYSIS FROM THE MANUFACTURER IS PENDING. (B)(6) 2014- AN ANALYSIS REVEALED THE REPORTED EVENT RESULTED FROM DATA ALTERED IN DEVICE MEMORY. THE FINAL ANALYSIS FROM THE MANUFACTURER IS PENDING. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(6) 2013- A PRELIMINARY ANALYSIS FROM THE MANUFACTURER WAS RECEIVED ON (B)(6) 2013 STATING THAT THE DEVICE MAY REMAIN IMPLANTED, MORE DETAILS WILL BE PROVIDED LATER. A SUBSEQUENT ANALYSIS FROM THE MANUFACTURER IS PENDING. (B)(6) 2014 AN ANALYSIS REVEALED THE REPORTED EVENT RESULTED FROM DATA ALTERED IN DEVICE MEMORY. THE FINAL ANALYSIS FROM THE MANUFACTURER IS PENDING. (B)(6) 2014 METHOD CODE : THE DEVICE REMAINS IMPLANTED, THEREFORE PROGRAMMER FILES FROM THE IMPLANT DAY WERE ANALYZED RESULT CODE : PLEASE REFER TO THE ATTACHED ANALYSIS, (B)(4). CONCLUSION : THE ROOT CAUSE OF THE MULTIPLE DATA ALTERATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SORIN CRM USA, INC REPRESENTATIVE CALLED TECHNICAL SERVICES FOLLOWING THE IMPLANT OF A PARADYM RF 9750 SN (B)(4), FOR TECHNICAL ASSISTANCE. THE CALLER HAD QUESTIONS ABOUT 2 WARNINGS THAT WERE NOTICED PRIOR TO IMPLANT BUT THE IMPLANTER THOUGHT THE MESSAGES WOULD CLEAR FOLLOWING IMPLANT. TESTING DURING IMPLANT SHOWED NORMAL DEVICE OPERATION. NO UNUSUAL DEVICE OPERATION WAS OBSERVED. THE WARNING MESSAGES WERE OBSERVED PRIOR TO IMPLANT BUT THE CALLER BELIEVED THE MESSAGE WOULD RESET ONCE IMPLANTED. THE RESET OCCURRED TWO DAYS BEFORE THE 9750 WAS REPORTEDLY SHIPPED FROM THE (B)(4) FACILITY ON (B)(4) 2013. THIS RESET IS BELIEVED TO HAVE OCCURRED WHILE ON THE SHELF AT THE (B)(4) FACILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SORIN (B)(4) INC. REPRESENTATIVE CALLED TECHNICAL SERVICES FOLLOWING THE IMPLANT OF A PARADYM RF 9750 SN (B)(4), FOR TECHNICAL ASSISTANCE. THE CALLER HAD QUESTIONS ABOUT 2 WARNINGS THAT WERE NOTICED PRIOR TO IMPLANT BUT THE IMPLANTER THOUGHT THE MESSAGES WOULD CLEAR FOLLOWING IMPLANT. TESTING DURING IMPLANT SHOWED NORMAL DEVICE OPERATION. NO UNUSUAL DEVICE OPERATION WAS OBSERVED. THE WARNING MESSAGES WERE OBSERVED PRIOR TO IMPLANT BUT THE CALLER BELIEVED THE MESSAGE WOULD RESET ONCE IMPLANTED.THE RESET OCCURRED TWO DAYS BEFORE THE 9750 WAS REPORTEDLY SHIPPED FROM THE (B)(4) FACILITY ON (B)(6) 2013. THIS RESET IS BELIEVED TO HAVE OCCURRED WHILE ON THE SHELF AT THE (B)(4) FACILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SORIN CRM USA, INC. REPRESENTATIVE CALLED TECHNICAL SERVICES FOLLOWING THE IMPLANT OF A PARADYM RF 9750 SN (B)(4), FOR TECHNICAL ASSISTANCE. THE CALLER HAD QUESTIONS ABOUT 2 WARNINGS THAT WERE NOTICED PRIOR TO IMPLANT BUT THE IMPLANTER THOUGHT THE MESSAGES WOULD CLEAR FOLLOWING IMPLANT. TESTING DURING IMPLANT SHOWED NORMAL DEVICE OPERATION. NO UNUSUAL DEVICE OPERATION WAS OBSERVED. THE WARNING MESSAGES WERE OBSERVED PRIOR TO IMPLANT BUT THE CALLER BELIEVED THE MESSAGE WOULD RESET ONCE IMPLANTED.THE RESET OCCURRED TWO DAYS BEFORE THE 9750 WAS REPORTEDLY SHIPPED FROM THE (B)(6) FACILITY ON (B)(6) 2013. THIS RESET IS BELIEVED TO HAVE OCCURRED WHILE ON THE SHELF AT THE (B)(6) FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611937 PARADYM RF CRT IMPLANTABLE CARDIAC DEFIBRILLATOR NIK SORIN GROUP ITALIA S.R.L. 9750

    Patients

    Seq Age Sex Outcome Treatment
    1