BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2203362 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01305
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DISTAL SEGMENT WAS RETURNED AND ANALYZED. ANALYSIS FOUND THE DISTAL CONDUCTOR WAS FRACTURED. BLOOD/BODY FLUID WAS NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED.

    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 DISTAL SEGMENT WAS RETURNED AND ANALYZED. ANALYSIS FOUND THE DISTAL CONDUCTOR WAS FRACTURED. BLOOD/BODY FLUID WAS NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD BEEN PREVIOUSLY CAPPED/UNUSABLE IN 2005 DUE TO OVERSENSING. THE LEAD WAS EXTRACTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD BEEN PREVIOUSLY CAPPED/UNUSABLE IN 2005 DUE TO OVERSENSING. THE LEAD WAS EXTRACTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY AND NOISE OVERSENSING WAS NOTED. THE DEVICE WAS TURNED OFF AND A LIFE VEST WAS PLACED ON THE PATIENT UNTIL THE LEAD REVISION COULD BE PERFORMED. THE 6943 LEAD WAS REPORTED TO HAVE BEEN PREVIOUSLY CAPPED/UNUSABLE IN 2005 DUE TO OVERSENSING. BOTH LEADS WERE EXTRACTED AND THE 6949 WAS REPLACED. AT THE TIME OF THE CHANGE OUT, THE 6949 LEAD EXHIBITED HIGH IMPEDANCES AND NOISE OVERSENSING INDICATIVE OF A LEAD FRACTURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 7223CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7223X IMPLANTABLE PACEMAKER/CARDIO/DEFIB