BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1071961 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03409
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 28, 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
    UT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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: NO ANOMALIES WERE FOUND. H3 OTHER TEXT : IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT RECEIVED 15 SHOCKS. SHE STATED THE "DEVICE MALFUNCTIONED." FOLLOW-UP INFORMATION REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER BEING SHOCKED MULTIPLE TIMES. THE DEVICE WAS TURNED OFF AND REPLACED THE NEXT DAY. THE REASON FOR DEVICE REPLACEMENT WAS NOT AVAILABLE. THE LEAD WAS CAPPED AND REPLACED DUE TO FRACTURE. ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED REPORTED MULTIPLE SHOCKS DUE TO NOISE. NO CAPTURE AND LEAD FRACTURE WAS ALSO NOTED. IT WAS INDICATED THE DEVICE WAS ELECTIVELY REPLACED DUE TO THE LEAD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO CONCLUSION CAN BE DRAWN CAPTURE, FAILURE TO LEAD(S), FRACTURE OF SHOCK, INAPPROPRIATE NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT RECEIVED 15 SHOCKS. SHE STATED THE "DEVICE MALFUNCTIONED." FOLLOW-UP INFORMATION REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER BEING SHOCKED MULTIPLE TIMES. THE DEVICE WAS TURNED OFF AND REPLACED THE NEXT DAY. THE REASON FOR DEVICE REPLACEMENT WAS NOT AVAILABLE. THE LEAD WAS CAPPED AND REPLACED DUE TO FRACTURE. ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED REPORTED MULTIPLE SHOCKS DUE TO NOISE. NO CAPTURE AND LEAD FRACTURE WAS ALSO NOTED. IT WAS INDICATED THE DEVICE WAS ELECTIVELY REPLACED DUE TO THE 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 Required Intervention 4194 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD