MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Unintended Collision (1429); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)

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 heath care professional (hcp) via a manufacturer representative reported a consumer was getting stimulation in the pocket site.It was unknown when this started.The hcp noted impedances were "jumping around' and an endoscopy showed a bulge indicating a potential lead migration.The hcp was planning on replacing the system.Additional information received from the representative reported the cause of the potential migration of the lead was unknown and the issue had not been resolved.Information received from the consumer reported experiencing painful shocking along where the leads were, which started mid (b)(6) 2016.The shocking sensation was getting worse.She had followed up with her hcp, who performed multiple procedures with the consumer (x-ray, ct scan) and it was determined she needed to have her whole system replaced.They had been working with the representative in the area and had not heard back from him yet; they were waiting to schedule the replacement surgery.The consumer noted she had fallen on her implant about three weeks.

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6069599
• MDR Text Key: 58847565
• Report Number: 3004209178-2016-22964
• Device Sequence Number: 1
• Product Code: LNQ
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Date Device Manufactured: 05/31/2012
• 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: 43 YR