BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA SR

    MDR report key: 1925802 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06349
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 11, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE PRIMARY ANLYSIS REVEALED THAT THERE WERE NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INTERMITTENT LEFT UPPER CHEST AND LEFT ARM "TWITCHING SENSATION", AND PERICARDIAL EFFUSION. THE TWITCHING DID NOT CORRESPOND CONSISTENTLY WITH PACING STIMULI AND COULD NOT BE EVOKED WITH PATIENT MOVEMENT. THE PATIENT NOTED THAT THE TWITCHING SENSATION WAS LESS INTENSE IN UNIPOLAR THAN BIPOLAR CONFIGURATION, AND WHEN PACING WAS INHIBITED. THE DEVICE HAD MIGRATED MORE LATERALLY THAN WHERE IT HAD BEEN IMPLANTED ABOUT 2 MONTHS AGO. THE PHYSICIAN ELECTED TO IMPLANT A NEW SYSTEM. THE DEVICE WAS REMOVED AND REPLACED. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. SESR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| L| R