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 09/12/2017

Event Type  malfunction  

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) reported on behalf of a healthcare provider (hcp) that during a procedure the hcp snapped the lead due to user error.The hcp stated that they just handled the lead poorly and nothing was wrong with the lead.The lead was never implanted.No further complications were reported/anticipated.

• 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: 6926829
• MDR Text Key: 89542402
• Report Number: 3007566237-2017-04246
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169887589
• UDI-Public: 00643169887589
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2019
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• Date Device Manufactured: 08/08/2017
• 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 Age: 49 YR