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

Model Number 37800

Device Problems Unstable (1667); Environmental Compatibility Problem (2929)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069); Ambulation Difficulties (2544)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported that while on a flight their implantable neurostimulator (ins) flipped horizontally and it was really painful and was hitting the belt buckle of the airplane seat and someone had to help them out of the seat.They could not carry their bags.The patient stated that normally the ins was flushed to the skin of their stomach.It took a week to flatten out and they could not bend over and the same thing happened on their flight home.They spoke to their healthcare provider and they stated that it may be from the cabin pressure.The patient also mentioned that they got an infection from the implant surgery and had a ct scan that showed the ins was in a pouch/sack of liquid.The hcp said that could happen and it was not abnormal.It was not something they wanted the patient to have forever, but that the patient would need another ct scan in a year.They wondered if that had anything to do with the ins moving around.The ins was indicated for gastric stimulation.

Event Description

Additional information from the patient reported they took antibiotics for the infection and the pocket of fluid was not resolved.They would have another ct scan (b)(6) 2017 to see what it would look like a year later.

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: 6324063
• MDR Text Key: 67205917
• Report Number: 3004209178-2017-03648
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Date Device Manufactured: 06/22/2016
• 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
• Patient Age: 37 YR