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 Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3116, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

It was reported that the healthcare provider replaced the leads due to fractured on (b)(6) 2015.The patient have a medical history of severe gastroparesis and chronic struggles with anorexia.The patient was reported alive with no injury as of (b)(6) 2015 during device follow up.There were no patient symptoms/injuries related to this event.The indications for use for this patient was gas trointestinal/pelvic floor.Additional information has been requested but was not available as of the date of this report.A follow-up report will be made if additional information becomes available.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the manufacturers' representative (rep) reported that she learned the patient had 2 lead revisions.The first lead revision was performed on (b)(6) 2015.The patient had presented with a fluttering sensation in her abdomen.She had both leads replaced.At the time of this report, the patient was doing fine and there was no further information.

• 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; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5267478
• MDR Text Key: 32688834
• Report Number: 3007566237-2015-03627
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2015
• Device Model Number: 4351-35
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2016
• Date Device Manufactured: 12/17/2013
• 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: 00069 YR