BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3182616 · Received June 21, 2013

    Report

    Report Number
    3007566237-2013-02053
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    October 31, 2012
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3116, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 4351, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    O'LOUGHLIN, P. M., GILLIAM, A. D., SHABAN, F., VARMA, J. S.. PRE-OPERATIVE GASTRIC EMPTYING TIME CORRELATES WITH CLINICAL RESPONSE TO GASTRIC ELECTRICAL STIMULATION IN THE TREATMENT OF GASTROPARESIS. THE SURGEON: JOURNAL OF THE ROYAL COLLEGES OF SURGEONS OF EDINBURGH AND IRELAND. 2013;11(3):134-140. DOI: 10.1016/J.SURGE.2012.10.006. SUMMARY: GASTRIC ELECTRICAL STIMULATION (GES) MAY BE OF BENEFIT IN CASES OF GASTROPARESIS THAT FAIL TO RESPOND TO STANDARD MEDICAL THERAPY. RESPONSE TO THIS TREATMENT IS VARIED AND PREDICTION OF CLINICAL IMPROVEMENT IS DIFFICULT. THIS WAS A RETROSPECTIVE REVIEW AND SYMPTOM QUESTIONNAIRE SURVEY FOR ALL PATIENTS WHO UNDERWENT GES INSERTION IN A SINGLE INSTITUTION FROM NOVEMBER 2008 UNTIL MAY 2010 USING THE GASTROPARESIS CARDINAL SYMPTOM INDEX (GCSI). FOURTEEN OUT OF 17 PATIENTS WHO HAD GES INSERTION RESPONDED TO TELEPHONE OR POSTAL QUESTIONNAIRE. MEAN PRE-OPERATIVE GASTRIC EMPTYING TIME WAS 151 MIN (MEDIAN 146 MIN, RANGE 18E318). MEDIAN FOLLOW UP WAS 14 MONTHS (RANGE 7E25 MONTHS). THE MEAN REDUCTION IN GCSI SCORE AFTER GES INSERTION WAS 51% (13.4 VS 6.4, Z ¼ 0.0013). PERCENTAGE REDUCTION IN GCSI CORRELATED WITH PRE-OPERATIVE SOLID GASTRIC EMPTYING TIME ( P ¼ 0.0086). TWO PATIENTS WHO RESPONDED TO QUESTIONNAIRE REQUIRED DEVICE REMOVAL, ONE DUE TO A GASTRIC PERFORATION AND THE OTHER FOR DISCOMFORT RELATED TO THE IMPLANT AND A POOR CLINICAL RESPONSE. GES SIGNIFICANTLY IMPROVES SYMPTOMS OF GASTROPARESIS ON THE GCSI SCORE. NOT ALL PATIENTS RESPOND EQUALLY TO GES, AND RESPONSE MAY BE PREDICTED BY PRE-OPERATIVE SOLID GASTRIC EMPTYING TIMES. REPORTED EVENTS: 1 PATIENT HAD DEVICE REMOVED DUE TO GASTRIC PERFORATION WHICH OCCURRED 2 MONTHS FOLLOWING INSERTION OF DEVICE RELATED TO AN EPISODE OF VOMITING AND REQUIRED REPAIR OF PERFORATION BY OVERSEWING. ONE PATIENT HAD DEVICE REMOVED DUE TO DISCOMFORT RELATED TO IMPLANT AND POOR CLINICAL RESPONSE. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PATIENT HAD ONE EPISODE OF URINARY RETENTION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284015 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R