BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA IPG

    MDR report key: 8841690 · Received July 30, 2019

    Report

    Report Number
    3008973940-2019-02110
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 28, 2019
    Report Date
    August 20, 2019
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED AND PERFORATED THROUGH THE MYOCARDIUM, CAUSING A PERICARDIAL EFFUSION. IT WAS ADDITIONALLY REPORTED THAT IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EVENT, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS INITIALLY PROPHYLACTICALLY REPROGRAMMED AND LATER REPLACED. NO DEVICE MALFUNCTION WAS OBSERVED WHILE THE DEVICE WAS IN USE, HOWEVER, GIVEN THE POTENTIAL FOR LOSS OF DEVICE FUNCTIONALITY THE IPG WAS EXPLANTED AND REPLACED TO PRECLUDE HARM TO THE PATIENT. THE LEAD WAS EXPLANTED 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
    636087 SENSIA IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC SINGAPORE OPERATIONS SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 5076-58 LEAD, 5076-52 LEAD