BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3082865 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07019
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    August 20, 2010
    Report Date
    April 26, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS ((B)(4)) FOUND THAT THE INS BATTERY HAD REACHED NORMAL END OF LIFE WITH NO TELEMETRY AND NO OUTPUT. (B)(4).

    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 PATIENT'S DEVICE "SHOCKED" HER AND SHE FOUND OUT THE "LEADS WERE MESSED UP." THE PATIENT'S SYSTEM WAS REPLACED AND IT WAS MUCH BETTER. THE PATIENT STATED THE NEW DEVICE WAS WONDERFUL AND SHE WAS GETTING BACK TO BEING ABLE TO EAT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THEY RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER¿S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT INDICATED THEY TALKED WITH A MANUFACTURER¿S REPRESENTATIVE ON THE PHONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MUSCLE NEAR THE PATIENT'S STOMACH WOULD ¿JUMP¿ WHEN THEY WERE STIMULATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT SHE HAD SYMPTOMS OF HER STOMACH JUMPING AND IT OCCURRED FROM 2010 UNTIL HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHANGED IN 2012. HOWEVER, IT DID NOT HURT WHEN IT JUMPED. THE PATIENT REPORTED THAT THEY SAID IT WAS DEFECTIVE. THE PATIENT WAS TOLD THAT HER INSS SHOULD LAST FIVE TO TEN YEARS AND THEY ALL KEPT DYING. SHE HAD TWO TO THREE INSS BACK TO BACK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED DUE TO NORMAL BATTERY DEPLETION AND THERE WAS NO PATIENT INJURY. AS IT WAS PREVIOUSLY REPORTED THAT THE INS BATTERY LIFE DID NOT APPEAR TO MEET THE PATIENT'S EXPECTATIONS, IT WAS UNCLEAR IF BATTERY DEPLETION WAS NORMAL OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185680 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention