BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC IPG

    MDR report key: 8800443 · Received July 17, 2019

    Report

    Report Number
    2182208-2019-01296
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 17, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US AND ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. POSSIBLE MODELS ARE SENSIA AND OR ENPULSE. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/67 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. THE PMA NUMBER FOR THIS REPORT IS P010015. EPICARDIAL PACEMAKER AS A BRIDGE FOR PACEMAKER-DEPENDENT PATIENTS UNDERGOING EXPLANTATION OF INFECTED CARDIAC IMPLANTABLE ELECTRONIC DEVICES JOURNAL OF CARDIAC SURGERY. 2019; 34 (6): 424-427. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATORS (IPGS). THE AUTHORS DISCUSSED IMPLANTATION OF PERMANENT EPICARDIAL PACEMAKERS UTILIZING A SUBXIPHOIDAL APPROACH. THE ARTICLE SHOWED ONE PATIENT DEVELOPED AN EPIGASTRIC HERNIA AND UNDERWENT LAPAROSCOPIC HERNIOPLASTY, ONE PATIENT DEVELOPED A CLOSED PERICARDIAL FISTULA ASSOCIATED WITH THE EPIGASTRIC SUBCUTANEOUS TISSUE AND UNDERWENT OPEN SURGICAL FISTULA CLOSURE, TWO PATIENTS DEVELOPED INSUFFICIENT PACING AND A SECOND EPICARDIAL PACEMAKER WAS IMPLANTED, AND ONE PATIENT DEVELOPED AN INFECTION. THE DISPOSITION OF THE DEVICE ASSOCIATED WITH THE INFECTION IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593756 MEDTRONIC IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R ST. JUDE OR GREATBATCH PACING LEAD