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

Model Number 3116

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2017, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2017, product type: lead.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 that a patient had a severe infection at the battery pocket site.The leads and implantable neurostimulator (ins) were explanted.No further complications were reported/anticipated.

Manufacturer Narrative

Product problem is no longer applicable to this event.There was only an adverse event associated.A good faith effort will be made to obtain the applicable information relevant to the report.If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.

Manufacturer Narrative

Product id 435135 lot# serial# (b)(4) implanted: (b)(6)2012 explanted: (b)(6)2017 product type lead product id 435135 lot# serial# (b)(4) implanted: (b)(6)2012 explanted: (b)(6)2017 product type lead product id 435135 lot# serial# (b)(4) implanted: (b)(6)2012 explanted: (b)(6)2017.Product type lead product id 435135 lot# serial# (b)(4) implanted: (b)(6)2012 explanted: (b)(6)2017 product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient had the device removed but they left the very tip of the lead abandoned.No patient complications were reported as a result of this event.

• 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: 6638215
• MDR Text Key: 77499214
• Report Number: 3004209178-2017-12796
• 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,Followup,Followup,Followup
• Report Date: 05/15/2019

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: 08/14/2013
• 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: 06/08/2017
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: Not provided; 06/28/2017; 05/13/2019
• Supplement Dates FDA Received: 06/28/2017; 10/05/2017; 05/15/2019
• Date Device Manufactured: 02/21/2012
• 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