MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 4351-35

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  malfunction  

Event Description

The manufacture representative reported that the patient¿s healthcare provider broke the lead during the procedure.The manufacture representative noted that there was no issue with the product itself, the surgeon just broke it.No medical symptoms were reported.There were no further complications reported/anticipated.

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.

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 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6578504
• MDR Text Key: 75626372
• Report Number: 3007566237-2017-01949
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169175006
• UDI-Public: 00643169175006
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2018
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: Not provided; 05/19/2017
• Supplement Dates FDA Received: 06/01/2017; 10/04/2017
• Date Device Manufactured: 11/15/2016
• 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: 38 YR
• Patient Weight: 68