BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1875313 · Received October 19, 2010

    Report

    Report Number
    6000144-2010-05472
    Event Type
    Injury
    Date Received
    October 19, 2010
    Report Date
    October 28, 2024
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S18
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. CORRECTION: THE ORIGINAL REPORT WAS AGAINST THE (B)(4) 5076 LEAD. THIS LEAD IS STILL IN USE IN THE PATIENT. SUBSEQUENT INFORMATION WAS RECEIVED THAT INDICATED THAT THE 5076 LEAD THAT APPARENTLY FRACTURED WAS (B)(4) AND THAT THIS LEAD HAD BEEN INACTIVE SINCE 2007. THE (B)(4) 5076 LEAD WAS ATTEMPTED TO BE EXPLANTED DURING AN ICD UPGRADE PROCEDURE. THIS SUPPLEMENTAL CORRECTS THE ORIGINAL SUBMISSION BY REMOVING THE (B)(4) 5076 LEAD FROM THE REPORT, ADDING THE (B)(4) 5076 LEAD, REVISING THE EVENT DESCRIPTION AND REMOVING THE EVENT DATE AS THE DATE OF FRACTURE IS NOT KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS FRACTURED. THE PHYSICIAN TRIED TO PULL THE LEAD OUT BUT WAS UNSUCCESSFUL, SO THE LEAD WAS CAPPED. THE LEAD WAS REMOVED AND REPLACED. NO 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 67 YR Male Required Intervention 6949 IMPLANTABLE TACHY LEAD.| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB.| 7299 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD