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

Model Number 37800

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Swelling (2091); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3080, serial#: unknown, product type: lead.Other relevant device(s) are: product id: 3080, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the device was implanted on the right side and patient was complaining right site discomfort.Caller stated that the patient was a thin person and that the ins was not working for patient either but initially, it worked a little bit but then it never ever worked after tune-up.Caller went on to explain that the device was explanted over a year ago and after the explant, patient was having swelling and discomfort on his abdomen, patient notice an anchor was protruding from patient's abdomen.Anchor one: reports anchor was still attached to suture and was protruded from patient's abdomen.Caller further stated that the health care provider pulled the anchor and suture right off of patient's skin and pulled the whole thing right out.Caller reports this was sometimes between (b)(6) 2020.Anchor two: caller reports the second anchor started protruding from patient's abdomen a few days after (b)(6) 2020.Reports patient went to see his primary physician, and he too pulled the anchor and suture right out of patient's abdomen.Reports after the anchors/suture were pulled, patient felt better.Reviewed where anchors are on the lead.No further complication noted or anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10363618
• MDR Text Key: 201609948
• Report Number: 3004209178-2020-13426
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2020
• Date Device Manufactured: 12/13/2016
• 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