MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Vibration (1674); Device Operates Differently Than Expected (2913)

Patient Problem Twitching (2172)

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

The consumer reported that the implantable neurostimulator (ins) would twitch a lot, so they would take the patient to the healthcare provider (hcp) to fix it.Sometimes it would vibrate, and the hcp indicated that vibrating was ok, but the twitching was not.It was noted that the ins was replaced, and they had only been to see the hcp once since then.The date that this occurred was unknown.There were no further complications that have been reported as a result of this event.He indications for use were gastric stimulation and gastrointestinal/pelvic floor.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6848929
• MDR Text Key: 85144922
• Report Number: 2647346-2017-00026
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• 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
• Report Date: 09/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2004
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 09/07/2017
• Date Device Manufactured: 03/26/2003
• 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: 41 YR