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

Model Number 37800

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033); Scar Tissue (2060); Swelling (2091)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, serial#(b)(4), product type: lead.Product id: 4351-35, serial#(b)(4), product type lead.

Event Description

The consumer reported that a rash started shortly after implant in (b)(6) 2016 right around the implantable neurostimulator (ins) scar.It looked like the scar was sunk in.The patient saw 3 health care providers (hcps) and a dermatologist was looking into possible allergic reaction and questioned if there was any nickel in the implant.A hcp gave the patient a cream to use.Additional information received from the consumer reported that the patient had a red patch around the area where the device was implanted.It spread and spread, and though it was a rash, the patient went to see their managing hcp.The red patch had been there since the device was implanted in (b)(6) 2015.The color of redness varied at different times from a pale pink patch to a very angry red patch.The patient further reported that the rash had probably been going on since they got the device implanted, probably in (b)(6) 2015.The patient had followed-up with several hcps including their implanting hcp, their primary care physician (pcp), and another internal hcp and dermatologist.The pcp gave the patient a cream to put on it.The rash didn't itch or anything like that and they went back to have the managinghcp look at it.The managing hcp didn't know what it was and told the patient to see a dermatologist.The dermatologist said it looked like it may be an allergic reaction because the leads had nickel in them and maybe the patient had the allergic reaction because the lead had disconnected.The patient stated if the leads went through the skin they could have caused a rash, but an x-ray was done and showed the leads were fine.The patient got a cream a month back and when they we nt back it wasn't any better and the dermatologist didn't know what it was.It was getting to where the rash looked like someone slapped them on the stomach where the implant was.For the first time on (b)(6) 2016, the implant was swollen and looked like a big soft ball.The patient didn't know what was going on because they didn't have any allergic reactions to the other implants they had, even the temporary trial.The patient went back 1.5 weeks ago to see their hcp and the manufacturer representative and the hcp told them to go to the implanting surgeon and to take a picture of it.The surgeon didn't know what it was so they were going to go back on (b)(6) 2016 to get things looked at.The patient wondered if the implant could be moved to the other side to resolve the issue.The indication for use for this patient was gastric stimulation.Additional information from the manufacturing representative (rep) on behalf of the healthcare provider (hcp) reported the patient had a skin infection and the entire system was explanted.There were no external factors associated with the event.There was no report of diagnostics or troubleshooting.The issue was noted to be resolved at the time of the report.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6343248
• MDR Text Key: 67803740
• Report Number: 3004209178-2017-04205
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: 01/31/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 06/04/2015
• 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: 44 YR