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

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Urticaria (2278)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

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

The consumer reported that the patient had their device implanted 2 years ago as of (b)(6) 2016.The patient broke out in hives on (b)(6) 2016 and had them since.The patient had been to an allergist and had no allergies whatsoever, but they did have sensitive skin.If the patient wore jewelry that wasn't real for any length of time it would break them out.The patient's concern was that for some reason this was what was now happening with their gastric pacer.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

Manufacturer Narrative

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

Additional information received from the consumer reported that the patient basically lived off toast, so there was nothing new that they could connect the hives with.The patient had very sensitive skin and if they wore any type of metal for long, they broke out.The steps taken to resolve the hives were that the patient had allergy tests that were negative, blood work that was okay, prednisone made it spread more, and the biopsy was urticarial.No medications, cream, or wash had helped and the hives had not been resolved.

Manufacturer Narrative

Information references: the main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id :4351-35, serial# (b)(4), implanted: (b)(6) 2014, 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

Additional information received from the consumer reported that the patient had a biopsy done, which was positive for hives.The patient got a list of components in the gastric pacemaker and had an allergy patch test done and they were allergic to iridium.The patient thought this was used to coat the wires in the pacer.In any event, the patient would have to have the pacer removed.

Event Description

Additional information received from the health care provider (hcp) via a manufacturer representative reported that the patient was experiencing hives and was thought to be allergic to the leads.The patient met with their health care provider (hcp) and physician¿s assistant (pa) on (b)(6) 2016 and was given a list of components in the gastric pacer for them to be tested for.The patient had the patch test done and they were allergic to iridium, which they believed along with platinum was used to coat the wires.The hives were worse and awful and were driving the patient crazy.The patient was supposed to have an appointment with their hcp on (b)(6) 2016 and wondered why they needed another clinic visit prior to having surgery.The patient just wanted to go ahead and set the surgery for removal of the pacer.The patient¿s device was removed on (b)(6) 2016.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2019,product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The consumer reported that the patient had their device implanted 2 years ago as of (b)(6) 2016.The patient broke out in hives on additional information received from a manufacturer representative (rep).It was reported that the patient¿s implanted neurostimulator (ins) was removed on (b)(6) 2016.On (b)(4) 2019, the rep reported the implant was going to be removed on (b)(6) 2019.No further complications were reported or anticipated.

• 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: 5573140
• MDR Text Key: 42511826
• Report Number: 3004209178-2016-07338
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/11/2019

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: 04/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 06/21/2016; 09/16/2019
• Supplement Dates FDA Received: 05/10/2016; 06/21/2016; 07/13/2016; 09/21/2017; 10/11/2019
• Date Device Manufactured: 10/25/2013
• 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: 00058 YR