MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Disconnection (1171); High impedance (1291); Unintended Collision (1429); Unstable (1667)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 02/01/2016

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 manufacturing representative (rep) and the healthcare provider (hcp) reported that the patient was seen the wednesday prior to the report, and they had a motor vehicle accident back in (b)(6) 2016.They were having issues controlling their nausea and vomiting.The hcp checked the implantable neurostimulator (ins) and it showed an increase impedance >800.They turned it off and they were planning to revise it.The hpc noted that maybe the leads dislodged with the accident.They were planning to order a new ins in case that one was damaged.They were wondering a mva could cause a dislodgement or malfunction.The ins was indication for use was not clear at the time of the report.

Event Description

Additional information from the healthcare provider (hcp) reported that the generator was found detached from fascia, flipping.The leads were identified torn apart from the generator.A new device (leads and generator ) were placed after removing the broken one.The patient's symptoms improved and the high impedances were resolved.

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.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6291882
• MDR Text Key: 66214074
• Report Number: 3007566237-2017-00415
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2017

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 Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided; 03/16/2017
• Supplement Dates FDA Received: 03/29/2017; 09/29/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 49 YR