BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT VR

    MDR report key: 2200176 · Received August 10, 2011

    Report

    Report Number
    6000094-2011-01297
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYSIS REVEALED THERE WAS GROMMET DAMAGE. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE IMPLANT, THE DEFIBRILLATION IMPEDANCE WAS GREATER THAN 200 OHMS. THE PIN WAS RE-INSERTED ON SEVERAL OCCASIONS WITH THE SAME MEASUREMENT. WHEN TESTING THE DEVICE BY INDUCING VENTRICULAR FIBRILLATION, THE T-WAVE SHOCK WAS UNABLE TO INDUCE. THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION AND IT IS REPORTED THAT ALTHOUGH THE DEVICE WAS PROGRAMMED TO GIVEN 25 JOULES ON THERAPY ONE AND 35 JOULES ON THERAPY TWO, THE DELIVERED ENERGY WAS 0.8 JOULES AND 0.9 JOULES RESPECTIVELY. THE VENTRICULAR FIBRILLATION INDUCTION WAS REPEATED AND TESTED AND EXTERNAL DEFIBRILLATION WAS REQUIRED A SECOND TIME. THE DELIVERED ENERGY WAS REPORTED AS 0.5 JOULES AND 0.9 JOULES. THE DEVICE WAS REMOVED AND REPLACED AND THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D354VRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| L| R 4968 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD