BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1791413 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06983
    Event Type
    Injury
    Date Received
    August 10, 2010
    Report Date
    February 25, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    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: (B)(4) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HIS "HEART HURTS" WHEN THE PACEMAKER IS PACING THE HEART. PATIENT SAID WHEN HE IS SITTING DOWN, HE IS FINE AROUND "60" BUT "AS SOON AS I START TALKING, IT HURTS". PATIENT SAID THEY TURNED "OFF" THE LOWER LEAD, BECAUSE "I DIDN'T REALLY NEED IT" AND THEY "TURNED OFF RATE RESPONSE, BECAUSE THAT WAS REALLY HURTING". THE DEVICE WAS LATER EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention