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

Model Number 37800

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Vomiting (2144); Electric Shock (2554)

Event Date 06/28/2016

Event Type  malfunction  

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 they were on vacation and all of a sudden they got a sharp shooting pain, randomly, and then they started feeling a piece where the shocking was.Every couple of seconds they would feel it.Like every 4-6 feet they would feel it and it was driving them insane.It hurt and it was out of the blue.The shocking was still occurring at the time of the report.The patient mentioned that the shocking had occurred once before in (b)(6) 2017 and the healthcare provider (hcp) had to turn one of the leads off because of it.Now all of a sudden the shocking came back.The patient mentioned that they bumped their stimulator with a suitcase on (b)(6) 2017 but the shocking didn't happen right away, but shortly after on (b)(6) 2017.The patient also noted that this was their second implant and since the battery replacement, they have had trouble.When they first got the battery replaced, they were puking every single day, which was totally the pacemaker.They stated that the first device had always helped and they realized that the old device had settings that went from 30-40 and they think they were at a 3, which the didn't even exist for the new device, which caused a lot of trouble.It was reviewed for the patient to follow up with a managing hcp.No further complications were reported/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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6761139
• MDR Text Key: 81635237
• Report Number: 3004209178-2017-16093
• 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
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2017
• Date Device Manufactured: 03/05/2015
• 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 Age: 21 YR