MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number	4351-35
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: product id: 37800, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.
Event or Problem Description
A manufacturing representative (rep) reported that during a procedure, the healthcare provider was implanting the lead robotically.After they implanted the electrode, the prolene suture attached to the needle snapped.The hcp drove the remaining suture end through one of the eyelets on the silicone disk instead of driving the needle through the center of the disk.He finished the case with no problem and the disk was laying flat on the stomach as they desired.It was noted that the issue was resolved at the time of the report.There was no surgical intervention and no patient symptoms reported.The indication for use was for gastric stimulation/gastrointestinal/pelvic floor.
Additional 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
• Common Device Name: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6278278
• Report Number: 3007566237-2017-00274
• Device Sequence Number: 1248654
• Product Code: LNQ
• UDI-Device Identifier: 00643169175006
• UDI-Public: 00643169175006
• Combination Product (Y/N): N
• PMA/510(K) Number: H990014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2018
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2016
• Supplement Date Received by Manufacturer: 12/30/2016
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR