BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 987671 · Received January 10, 2008

    Report

    Report Number
    2649622-2008-00214
    Event Type
    Death
    Date Received
    January 10, 2008
    Date of Event
    October 12, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT IS DECEASED AND FURTHER INDICATED THAT THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4): PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: PROXIMAL CONDUCTOR FRACTURED; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) LEAD WAS EXPLANTED AND REPLACED DUE TO INAPPROPRIATE SHOCKS, HIGH PACING IMPEDANCE OF GREATER THAN 2000 OHMS, OVERSENSING, AND LOSS OF CAPTURE. FURTHER INFORMATION FROM AN ATTORNEY ALLEGES THE PATIENT SUSTAINED INJURY AS A RESULT OF A DEFECTIVE LEAD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. FURTHER ALLEGED THAT THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY", THAT THE PATIENT "EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, FRACTURE OR OTHER INJURY REQUIRING MEDICAL INTERVENTION INCLUDING BUT NOT LIMITED TO SURGERY, REMOVAL AND/OR REPLACEMENT OF THE DEFECTIVE [LEAD]", AND THAT THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) LEAD WAS EXPLANTED AND REPLACED DUE TO INAPPROPRIATE SHOCKS, HIGH PACING IMPEDANCE OF GREATER THAN 2000 OHMS, OVERSENSING, AND LOSS OF CAPTURE. FURTHER INFORMATION FROM AN ATTORNEY ALLEGES THE PATIENT SUSTAINED INJURY AS A RESULT OF A DEFECTIVE LEAD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. A LAWSUIT FURTHER ALLEGED THAT THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY", THAT THE PATIENT "EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, FRACTURE OR OTHER INJURY REQUIRING MEDICAL INTERVENTION INCLUDING BUT NOT LIMITED TO SURGERY, REMOVAL AND/OR REPLACEMENT OF THE DEFECTIVE [LEAD]", AND THAT THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (RIGHT VENTRICULAR) LEAD WAS EXPLANTED AND REPLACED DUE TO INAPPROPRIATE SHOCKS, HIGH PACING IMPEDANCE OF GREATER THAN 2000 OHMS, OVERSENSING, AND LOSS OF CAPTURE. FURTHER INFORMATION FROM AN ATTORNEY ALLEGES THE PATIENT SUSTAINED INJURY AS A RESULT OF A DEFECTIVE LEAD. 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 FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R 5076 IMPLANTABLE PACING LEAD| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB