BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3968376 · Received July 30, 2014

    Report

    Report Number
    3007566237-2014-02128
    Event Type
    Injury
    Date Received
    July 30, 2014
    Report Date
    February 24, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: REPORT SUBMITTED IN ERROR AS EVENT WAS PREVIOUSLY REPORTED. SEE ATTACHMENT FOR 12 CASES OF INFECTION. EVENTS ALREADY BEEN REPORTED IN MDRS AND THEREFORE SHOULD NOT HAVE BEEN REPORTED AGAIN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: EVENT WAS PREVIOUSLY REPORTED IN THE FOLLOWING MANUFACTURING REPORTS: 6000032-2001-00652, 6000032-2001-00920, 6000032-2004-01589, 6000032-2004-00170, 6000032-2004-00216, 6000032-2004-00316, 6000032-2004-00393, 6000032-2005-00222, 6000032-2004-00511, 6000032-2004-00918, 6000032-2004-01092, AND 6000033-2004-01500.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 12 PATIENTS WITH INFECTION OF THE SUBCUTANEOUS PACEMAKER SITE/POCKET. IT WAS STATED THAT THE EVENTS WERE TREATED BY DEVICE REMOVAL, DEVICE REPOSITIONING, OR ANTIBIOTIC TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445393 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention