BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3027866 · Received March 29, 2013

    Report

    Report Number
    3007566237-2013-00954
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    January 4, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID 3116, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3116, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID 3116, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3116, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3116, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3116, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TIMRATANA, P., EL-HAYEK, K., SHIMIZU, H., KROH, M., CHAND, B. LAPAROSCOPIC GASTRIC ELECTRICAL STIMULATION FOR MEDICALLY REFRACTORY DIABETIC AND IDIOPATHIC GASTROPARESIS. JOURNAL OF GASTROINTESTINAL SURGERY: OFFICIAL JOURNAL OF THE SOCIETY FOR SURGERY OF THE ALIMENTARY TRACT. 2013;17(3):461-470. DOI: 10.1007/S11605-012-2128-7. SUMMARY: GASTRIC ELECTRICAL STIMULATOR (GES) IMPLANTATION IS EFFECTIVE IN CERTAIN PATIENTS WITH GASTROPARESIS; HOWEVER, LAPAROTOMY IS OFTEN EMPLOYED FOR PLACEMENT. THE AIM OF THIS STUDY IS TO REVIEW OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC GES THERAPY FOR DIABETIC AND IDIOPATHIC GASTROPARESIS AT A LARGE REFERRAL CENTER. PATIENTS WHO UNDERWENT GES (ENTERRA THERAPY SYSTEM; MEDTRONIC, MINNEAPOLIS, MN) IMPLANTATION WITH SUBSEQUENT INTERROGATION AND PROGRAMMING BETWEEN (B)(6) 2001 AND (B)(6) 2011 WERE ANALYZED. A TOTAL OF (B)(4) PATIENTS UNDERWENT GES PLACEMENT OR REVISION DURING THE STUDY PERIOD. (B)(4) PATIENTS UNDERWENT PRIMARY GES AT OUR INSTITUTION, WHILE (B)(4) PATIENTS UNDERWENT GES GENERATOR REVISION AT OUR INSTITUTION. PRIMARY OPERATIONS WERE COMPLETED LAPAROSCOPICALLY IN (B)(4) CASES, WITH ONE CONVERSION TO LAPAROTOMY DUE TO SEVERE ADHESIONS. AT A MEAN FOLLOW-UP OF 27 MONTHS ((B)(4)), SYMPTOM IMPROVEMENT WAS ACHIEVED IN (B)(4) AND WAS SIMILAR FOR BOTH THE DIABETIC AND IDIOPATHIC SUBGROUPS. NEED FOR SUPPLEMENTAL NUTRITION (ENTERAL AND/OR PARENTAL) DECREASED IN BOTH GROUPS. GES PLACEMENT IS FEASIBLE USING A LAPAROSCOPIC APPROACH. MEDICAL REFRACTORY GASTROPARESIS IN THE DIABETIC AND IDIOPATHIC GROUPS HAD SIGNIFICANT SYMPTOM IMPROVEMENT WITH NO DIFFERENCE BETWEEN THE TWO GROUPS. NEED FOR SUPPLEMENTAL NUTRITION IS DECREASED FOLLOWING GES. REPORTED EVENTS: (B)(4) PATIENTS EXPERIENCED IMPLANTABLE NEUROSTIMULATOR (INS) MALPOSITIONING AND REVISION. (B)(4) PATIENT(S) EXPERIENCED SKIN EROSION OVER THE LEAD WITH SUBSEQUENT REPLACEMENT OF THE LEAD. (B)(4) PATIENT EXPERIENCED SKIN NECROSIS REQUIRING DEVICE REMOVAL. (B)(4) PATIENTS EXPERIENCED INS MALFUNCTION SECONDARY TO ELECTRICAL MALFUNCTION. (B)(4) PATIENT EXPERIENCED A BROKEN LEAD. (B)(4) PATIENTS WHO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT HAD THE INS SYSTEM REMOVED AND RECEIVED GASTRIC BYPASS SURGERY. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130271 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention