BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3230658 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11876
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S SYSTEM WAS BEING EXPLANTED DUE TO MINIMAL EFFICACY FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S SYSTEM WAS EXPLANTED BECAUSE THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT PROGRAMS HAD BEEN CHANGED MULTIPLE TIMES PRIOR TO EXPLANT. THERE WERE NO ABNORMAL IMPEDANCES NOTED. THE PATIENT OUTCOME WAS NON-SERIOUS INJURY/ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330088 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention