BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1922165 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12779
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA)<=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2010 11:19:33 AND (B)(6) 2010 12:30:55. VF (VENTRICULAR FIBRILLATION)<=210 MS BETWEEN (B)(6) 2010 11:19:37 AND (B)(6) 2010 15:40:13.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROGRAM OF THE RIGHT VENTRICULAR CHAMBER DISPLAYED CONSISTENT OVERSENSING. AN INVASIVE TROUBLESHOOTING REVEALED AN INSULATION BREACH IN THE RIGHT VENTRICULAR PACE/SENSE LEAD JUST DISTAL OF THE IS-1 CONNECTOR SLEEVE. THE LEAD WAS DISCONNECTED/ABANDONED AND REPLACED WITH THE CHRONIC RIGHT VENTRICULAR DEFIBRILLATION LEAD IS-1 CONNECTOR. A PIN PLUG WAS INSTALLED IN THE ATRIAL PORT OF THE DEVICE. THE DEVICE WAS REPROGRAMMED TO SINGLE CHAMBER FUNCTIONALITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROGRAM OF THE RIGHT VENTRICULAR CHAMBER DISPLAYED CONSISTENT OVERSENSING. AN INVASIVE TROUBLESHOOTING REVEALED AN INSULATION BREACH IN THE RIGHT VENTRICULAR PACE/SENSE LEAD JUST DISTAL OF THE IS-1 CONNECTOR SLEEVE. THE LEAD WAS DISCONNECTED/ABANDONED AND REPLACED WITH THE CHRONIC RIGHT VENTRICULAR DEFIBRILLATION LEAD IS-1 CONNECTOR. A PIN PLUG WAS INSTALLED IN THE ATRIAL PORT OF THE DEVICE. THE DEVICE WAS REPROGRAMMED TO SINGLE CHAMBER FUNCTIONALITY. IT WAS FURTHER REPORTED THAT THERE WAS POCKET EROSION AND LEAD WILL BE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4194 IMPLANTABLE PACING LEAD