MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Pocket Erosion (2013); Impaired Healing (2378); Insufficient Information (4580)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Date is estimated; month and year are valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/ pelvic floor.It was reported that the reason for the call was to report that with their first implant, within six months after the date of implant, the ins was poking out and hurt.They said the pocket never formed properly.The patient said they used a hernia support band, which did not help.They said the surgeon had to switch it down, and the revision resolved the issue.No further action was taken by the manufacturer help line.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13457204
• MDR Text Key: 285347838
• Report Number: 3004209178-2022-01648
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2022
• Date Device Manufactured: 10/12/2015
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female