BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3970512 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13744
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 9, 2014
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THREE DAYS PRIOR TO THE REPORT THE PATIENT STARTED THROWING UP AND SHE NEEDED HER DEVICE CHECKED. IT WAS REPORTED THAT THE PATIENT HAD A KIDNEY AND PANCREAS TRANSPLANT IN (B)(6) OF LAST YEAR AND SHE WAS AFRAID SHE COULD NOT KEEP HER REJECTION MEDICATION DOWN DUE TO THROWING UP. IT WAS NOTED THAT THE PATIENT WAS TOLD THAT SHE COULD NOT HAVE THE DEVICE CHECKED FOR A WEEK AT THE DOCTOR¿S OFFICE AND THE DOCTOR NO LONGER WORKED WITH THE THERAPY AND DID NOT HAVE A PHYSICIAN PROGRAMMER. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT MADE AN APPOINTMENT TO HAVE HER DEVICE CHECKED WITH A DIFFERENT DOCTOR. TEN DAYS LATER, IT WAS REPORTED THAT THERE WAS AN END OF SERVICE/END OF LIFE MESSAGE AND THE BATTERY RAN DOWN ON THE IMPLANTABLE NEUROSTIMULATOR (INS) ABOUT TWO WEEKS PRIOR. IT WAS NOTED THAT THE PATIENT SAW THEIR HEALTHCARE PROVIDER AND THE INS WAS CHECKED. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER SAW ¿LOW BATTERY¿ AND BOOSTED UP THE VOLTAGE. IT WAS NOTED THAT THAT LASTED HALF A DAY AND THEN THE INS WAS NOT WORKING AT ALL. THE REPORTER STATED THAT IT WAS RECOMMENDED THAT THE INS BE REPLACED. IT WAS REPORTED THAT THE PATIENT WAS THROWING UP THE MEDICATIONS SHE WAS TAKING DUE TO HER KIDNEY AND PANCREAS TRANSPLANT. FIVE DAYS LATER, IT WAS REPORTED THAT THERE WAS NORMAL BATTERY DEPLETION WITH A ¿LOW¿ INDICATION. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT¿S REPLACEMENT WOULD BE SCHEDULED THIS MONTH. IT WAS REPORTED THAT THE PATIENT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED ON (B)(6) 2014 DUE TO NORMAL BATTERY DEPLETION. THE REPORTER STATED THAT THE PATIENT HAD A KIDNEY AND PANCREAS TRANSPLANT IN (B)(6) 2013, STIMULATION WORKED FINE UNTIL THE PREVIOUS DEVICE REACHED END OF SERVICE (EOS), AND THE PATIENT WAS HAVING TROUBLE KEEPING HER IMMUNOSUPPRESSANT MEDICATIONS DOWN DUE TO GASTROPARESIS. THE REPORTER STATED THAT IT TOOK FIVE WEEKS BETWEEN THE BATTERY REACHING EOS AND REPLACEMENT. IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR OTHER CONDITIONS UNRELATED TO DEVICE THERAPY AND PRIOR TO THE REPLACEMENT PROCEDURE. IT WAS REPORTED THE LAST TIME THE PATIENT¿S BATTERY DIED THE PATIENT ENDED UP IN THE HOSPITAL BECAUSE THEY COULD NOT KEEP THEIR REJECTION MEDICINE DOWN FOR THEIR KIDNEY AND PANCREAS TRANSPLANTS. ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER STATED THE CAUSE OF THE EVENT WAS A DEAD BATTERY. IT WAS NOTED THE BATTERY DEPLETION WAS NORMAL AND IT WAS REPLACED ON (B)(6) 2014. IT WAS STATED THE PATIENT HAD SYMPTOMS OF GASTROPARESIS. THE PATIENT¿S OUTCOME WAS REPORTED AS NON-SERIOUS INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447886 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization