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

Model Number 3116

Device Problems Unintended Collision (1429); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 03/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 12-jun-2016, udi#: (b)(4).Product id: 4351-35, serial/lot #: (b)(4), ubd: 12-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 consumer (con) and from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that about 4 months ago, the patient¿s symptoms started getting worse and the patient knew they were at the highest level.It was noted that the implant was ¿not working¿ and the battery had ¿died¿; it was then reported that the patient was not sure if the battery had died yet.It was noted that the patient had an immune disorder and didn't want to have surgery if they didn't need to remove the battery when it is dead, and they were thinking about getting a feeding tube.The patient would be seeing their doctor on (b)(6) 2018.On (b)(6) 2018, the hcp reported that the battery was fine, but the leads were loose.No further complications were reported/anticipated.

Manufacturer Narrative

Continuation of d11: product id 4351-35 lot# serial# (b)(4) implanted: 2014-(b)(6) explanted: product type lead product id 4351-35 lot# serial# (b)(4) implanted: 2014-(b)(6) explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare professional (hcp).It was reported that the patient had a fall and their problems increased after that.The patient was taken to the operating room (or) and the leads were detached, reattached, and tightened with good effect.

• 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: 7953005
• MDR Text Key: 124348203
• Report Number: 3004209178-2018-22726
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• Date Device Manufactured: 07/10/2014
• 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: 45 YR
• Patient Weight: 64