BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1071949 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03392
    Event Type
    Death
    Date Received
    July 10, 2008
    Date of Event
    June 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0067-007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT RECEIVED INAPPROPRIATE SHOCKS, OVERSENSING AND NOISE WAS DETECTED. THE LEAD HAD APPARENT FRACTURE. THE PACE/SENSE PORTION OF LEAD WAS CAPPED AND PREVIOUSLY IMPLANTED LEAD WAS UNCAPPED AND USED FOR PACE/SENSE(2007). HIGH VOLTAGE PORTION OF THE LEAD REMAINED IN USE. PATIENT'S GRANDMOTHER REPORTED PATIENT HEARD PATIENT ALERT (2008). SHE WAS TRANSFERRED TO ANOTHER FACILITY FOR EXPLANT OF HIGH VOLTAGE LEAD. THE GRANDMOTHER REPORTS DURING EXTRACTION THE VENA CAVA WAS TORN, THE LUNG WAS CUT, AND PATIENT SUSTAINED BRAIN DAMAGE. PATIENT RECEIVED 14 UNITS OF BLOOD AS A RESULT. LEAD WAS NOT REPLACED AT THAT TIME, BUT INFORMATION RECEIVED LATER INDICATES A NEW HIGH VOLTAGE PACE/SENSE LEAD WAS IMPLANTED ON RIGHT SIDE. ADDITIONAL INFORMATION OBTAINED THROUGH A NEWSPAPER ARTICLE INDICTED FAMILY FEELS DEVICE CAUSED PATIENT'S DEATH. NO CONCLUSION CAN BE DRAWN INTERFERENCE LEAD(S), FRACTURE OF OVERSENSING SHOCK, INAPPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED INAPPROPRIATE SHOCKS, OVERSENSING AND NOISE WAS DETECTED. THE LEAD HAD APPARENT FRACTURE. THE PACE/SENSE PORTION OF LEAD WAS CAPPED AND PREVIOUSLY IMPLANTED LEAD WAS UNCAPPED AND USED FOR PACE/SENSE (2007). HIGH VOLTAGE PORTION OF THE LEAD REMAINED IN USE. PATIENT'S GRANDMOTHER REPORTED PATIENT HEARD PATIENT ALERT (2008). SHE WAS TRANSFERRED TO ANOTHER FACILITY FOR EXPLANT OF HIGH VOLTAGE LEAD. THE GRANDMOTHER REPORTS DURING EXTRACTION THE VENA CAVA WAS TORN, THE LUNG WAS CUT, AND PATIENT SUSTAINED BRAIN DAMAGE. PATIENT RECEIVED 14 UNITS OF BLOOD AS A RESULT. LEAD WAS NOT REPLACED AT THAT TIME, BUT INFORMATION RECEIVED LATER INDICATES A NEW HIGH VOLTAGE PACE/SENSE LEAD WAS IMPLANTED ON RIGHT SIDE. ADDITIONAL INFORMATION OBTAINED THROUGH A NEWSPAPER ARTICLE INDICTED FAMILY FEELS DEVICE CAUSED PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death| H| L| R 4193 IMPLANTABLE PACING LEAD| 7303 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD