MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erosion (1750); Complaint, Ill-Defined (2331); Test Result (2695)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: l:ead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 12-jul-2014, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 20-sep-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had a ct scan done and showed an intra-abdominal abscess with the gastric stimulator leads in connection with the abscess.The hcp accepted the patient for surgical intervention and did the emergent exploration.It was noted that the patient had had the stimulator for six years and was experiencing good results prior to this event; this issue was asymptomatically progressing.During the exploration, the hcp found the leads had eroded within the stomach and the abscess was drained.The small bowel was also severely thickened and required resection.There were no small bowel injuries or enterotomies seen; it was just severely inflamed, which was likely due to the adjacent abscess.At the time of the report, the patient was in the hospital on iv antibiotics.The patient was not febrile, but their white blood count (wbc) remained elevated and they were nil per os (npo) with a nasogastric tube (ngt) in place until they had a return of bowel function.This issue was noted to not be resolved at the time of the report and the battery was not the issue, but was explanted.No further complications were reported or anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7841737
• MDR Text Key: 119041101
• Report Number: 3004209178-2018-19761
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2018
• Date Device Manufactured: 08/29/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Weight: 83