BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 1719018 · Received June 11, 2010

    Report

    Report Number
    6000144-2010-02990
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    April 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED "SHARP JABS IN CHEST," NEAR PACEMAKER, SINCE 5 DAYS AFTER IMPLANT. SHE REPORTED "13 JABS SINCE LAST NIGHT AND IT IS HOT AFTERWARD." THE PATIENT HAD THE DEVICE CHECKED TWO DAYS PRIOR, AND THE DEVICE WAS "OK." FOLLOW-UP INFORMATION RECEIVED REPORTED THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE. THE PATIENT WAS PUT ON A PAIN MEDICATION, AND THE DOCTOR BELIEVED THE FEELING MAY BE COMING FROM THE DEVICE BEING CLOSE TO THE CHEST WALL. THE DEVICE ITSELF WAS NOT GETTING HOT, AND THERE WAS NO REPORTED NERVE STIMULATION. THE DEVICE REMAINS IN USE, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2010 (B)(4): ON (B)(6), 2010 THE PATIENT REPORTED FEELING "LITTLE SHOCKS" AND THAT THE PACEMAKER AREA "HURTS" AND SOMETIMES "BURNS". THE PATIENT ALSO REPORTED "LAST NIGHT I HAD SO MANY JABS I COULDN'T SLEEP". THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED "SHARP JABS IN CHEST," NEAR PACEMAKER, SINCE 5 DAYS AFTER IMPLANT. SHE REPORTED "13 JABS SINCE LAST NIGHT AND IT IS HOT AFTERWARD." THE PATIENT HAD THE DEVICE CHECKED TWO DAYS PRIOR, AND THE DEVICE WAS "OK." FOLLOW-UP INFORMATION RECEIVED REPORTED THERE WAS NO PERFORMANCE ISSUES WITH THE DEVICE. THE PATIENT WAS PUT ON A PAIN MEDICATION, AND THE DOCTOR BELIEVED THE FEELING MAY BE COMING FROM THE DEVICE BEING CLOSE TO THE CHEST WALL. THE DEVICE ITSELF WAS NOT GETTING HOT, AND THERE WAS NO REPORTED NERVE STIMULATION. THE DEVICE REMAINS IN USE, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 5072 X 2 IMPLANTABLE PACING LEADS