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

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 22-aug-2016, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 18-jun-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient.It was reported that their device battery and lead were explanted in (b)(6) 2018 due to lead erosion.The patient stated that they didn¿t remember the exact date of the explant, and they got their new implant on (b)(6) 2018.No further complications were reported or anticipated.Indication for use is gastrointestinal/pelvic floor.

• 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: 7879718
• MDR Text Key: 120381613
• Report Number: 3004209178-2018-20757
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/16/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/16/2018
• Date Device Manufactured: 07/17/2014
• 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