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

Model Number 37800

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Pocket Erosion (2013); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: date is approximate.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 gastrointestinal/ pelvic floor.It was reported that a while ago they started noticing that the neurostimulator felt like it was trying to eject itself from the body, they said it felt like a pushing sensation and it hurt at the distal end of the neurostimulator.They said it happened occasionally and they hadn't noticed any pattern, however it usually lasted a couple of hours, this time it began the night prior around 8:30 pm and it still hurt the morning of the report, they said they couldn't sleep the night prior.They stated they hadn't had any falls or trauma and hadn't done any strenuous physical activity.They were traveling and wouldn't be back for a few more days, they noted an appointment was scheduled to see their managing physician the following tuesday.They also noted the healthcare provider had taken x-rays in the past and checked the battery.They said the leads looked fine.The last general check was in may and the healthcare provider adjusted their impedance.They were redirected to their healthcare provider to further address the issue.

• 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: 12488234
• MDR Text Key: 271910715
• Report Number: 3004209178-2021-14027
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/17/2021
• Date Device Manufactured: 07/13/2017
• 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 Age: 53 YR