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

Model Number 3116

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Twiddlers Syndrome (2114)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 435135, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2017, product type lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type lead.Evaluation code-conclusion: applies to the ins, whereas applies to both leads.

Event Description

It was reported that the patient experienced a return of symptoms.The device was interrogated and was out of range.During the procedure, the patient¿s healthcare provider saw the twisted wires and realized that caused the lead to break.The patient breaking the lead was the environmental/external/patient factors that may had led or contributed to the issue.The patient¿s entire system was replaced and the patient¿s issue was resolved.It was further noted that the patient was flipping the device which caused the lead to break.The patient was reported to be alive with no injury.No further complications were reported.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6878898
• MDR Text Key: 86745521
• Report Number: 3004209178-2017-19691
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2017

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: 02/14/2013
• 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: 08/24/2017
• Initial Date FDA Received: 09/20/2017
• Date Device Manufactured: 08/16/2011
• 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 Weight: 88