BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3927479 · Received July 10, 2014

    Report

    Report Number
    6000032-2014-00141
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    December 17, 2001
    Report Date
    March 7, 2002
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 4351, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 4351, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2001, NOTING ¿LEADS IN PLACE.¿ IT WAS NOTED THAT THE PATIENT ¿COMPLAINED CHRONICALLY ABOUT PAIN AT POCKET SITE¿ PRIOR TO REPOSITION, SO A DECISION WAS MADE IN (B)(6) 2001 TO REMOVE THE DEVICE. IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT IMPROVEMENT OF HER SYMPTOMS OF GASTROPARESIS POST IMPLANT, BUT UNFORTUNATELY HAD UNRESOLVING PAIN. SEE MANUFACTURING REPORT #S 6000032-2014-00138 <(>&<)> 6000032-2014-00139.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404257 ENTERRA INTESTINAL STIMULATOR LNQ MDT SOFAMOR DANEK PUERTO RICO MFG 7425G

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Required Intervention