BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 2122960 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-00710
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S021
    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. EVALUATION SUMMARY: (B)(4): THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION COIL WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED. EVALUATION SUMMARY (B)(4) THE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND THE ANALYSIS REVEALED OVERSENSING. THERE WAS ONE VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) = 210 MS AVERAGE V-CYCLE ON (B)(4)-2009.

    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 PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DEFIBRILLATOR CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED. EVALUATION SUMMARY: (B)(4): THE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND THE ANALYSIS REVEALED OVERSENSING. THERE WAS ONE VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) = 210 MS AVERAGE V-CYCLE ON (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR SUBCUTANEOUS COIL WAS FRACTURED. THE COIL WAS EXPLANTED AND A BIVENTRICULAR SYSTEM WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBQ IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6996 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6835 COMPETITOR IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6835 COMPETITOR IMPLANTABLE PACING LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD