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

Model Number 37800

Device Problem Material Deformation (2976)

Patient Problems Dysphagia/ Odynophagia (1815); Therapeutic Response, Decreased (2271); Malaise (2359); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2006, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 13-jul-2008, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 13-jul-2008, 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) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient¿s surgeon took the complete system out and the leads were tangled up.The patient was sewn back up and was sent home.Afterwards, the patient couldn¿t eat anything without getting sick and they thought the surgeon made a mistake.No further complications were reported or anticipated.

Manufacturer Narrative

Continuation: product id 435135 lot# serial# (b)(4) implanted: 2006 (b)(6) explanted: 2018 (b)(6) product type lead product id 435135 lot# serial# (b)(4) implanted: 2006-(b)(6) explanted: 2018-(b)(6) product type lead patient code: couldn¿t swallow water, only thing that she could eat was ice cubes.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the consumer on september 10th reported she was waiting to have surgery scheduled again for implant to be put back in.The patient stated on (b)(5) 2018 everything was removed because the leads were damaged.The patient stated she wasn¿t sure whether the leads were still there or not.The patient stated they might have been taken out.The patient stated she couldn¿t swallow water currently as she had been sick and was waiting for the device to be implanted.The patient stated they were not sure when the device stopped working because the symptoms had returned.The patient noted the only thing that she could eat was ice cubes that all started on (b)(4).The patient noted she could not swallow on (b)(4).There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Product id: 435135, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2018, product type: lead; product id :435135, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a consumer (con).It was reported that the patient didn't know the leads were tangled.There was no change in activity that led to the leads being tangled.The patient couldn't eat or drink and was working on getting set up to have another device put in.

• 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: 7842314
• MDR Text Key: 119064069
• Report Number: 3004209178-2018-19781
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,Followup,Followup
• Report Date: 09/27/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/10/2018; 09/13/2018
• Supplement Dates FDA Received: 09/13/2018; 09/27/2018
• Date Device Manufactured: 10/12/2015
• 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: 86