BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1071962 · Received July 10, 2008

    Report

    Report Number
    6000144-2008-00162
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    March 28, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    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. 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. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. DEVICE OPERATED ACCORDING TO SPECIFICATIONS. ELECTIVE REPLACEMENT, SHOCK, INAPPROPRIATE, MALFUNCTION.

    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 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD