MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Break (1069); Low Battery (2584)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 435135, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2016, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2016, product type lead.

Event Description

The health care provider (hcp) reported that the lead fractured at mid-portion.It was unclear if both previous leads were fractured or if just 1 lead fractured.The patient had recurrent nausea and vomiting.The patient had battery depletion.The leads and implantable neurostimulator (ins) were removed and new leads and a new ins were implanted on (b)(6) 2016.The cause of the fractured leads and ins replacement was not determined.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

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
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6126708
• MDR Text Key: 60846287
• Report Number: 3004209178-2016-24680
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

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: 08/28/2013
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/24/2016
• Supplement Dates Manufacturer Received: 11/01/2016
• Supplement Dates FDA Received: 09/27/2017
• Date Device Manufactured: 03/09/2012
• 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: 59 YR