MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 13-dec-2009, udi#: (b)(4).Product id: 435135, serial/lot #: (b)(4), ubd: 13-dec-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of gastrointestinal/pelvic floor via a manufacturer representative (rep).It was reported that the patient had a device replacement for the entire system because one of the wires broke in half.The replacement was done on (b)(6) 2019.No further patient complications were reported as a result of this event.

Manufacturer Narrative

Product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp).They reported serial/lot number of the broken lead was unknown.The stated the cause of the broken lead was a possible lead migration out of the muscularis of the stomach as well as the broken lead.The broken lead was first noticed on (b)(6) 2019.They provided the patient¿s weight at the time of the event.They stated the entire system was replaced and they no longer had the devices.No patient complications were reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 8474467
• MDR Text Key: 140650394
• Report Number: 3004209178-2019-06518
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

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: 05/28/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 06/20/2019
• Date Device Manufactured: 12/13/2014
• 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: 56 YR
• Patient Weight: 110