MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number	4351-35
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received from a healthcare professional (hcp) via a manufacturer representative reported upon placing a 5 mm clip onto the prolene suture part of the lead, the suture snapped.The hcp was unable to place a second clip onto this particular lead, so he left it with 1 clip.It was unknown if any factors led to the event, or if any troubleshooting was performed.No actions were taken.The issue was resolved at the time of the report.No symptoms were reported.There were no further complications reported and/or anticipated.

• Brand Name: ENTERRA
• Common Device Name: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7079055
• Report Number: 3007566237-2017-05038
• Device Sequence Number: 19083827
• Product Code: LNQ
• UDI-Device Identifier: 00643169887589
• UDI-Public: 00643169887589
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: H990014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

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: 10/23/2019
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR