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

Model Number 3116

Device Problems Electro-Static Discharge (2149); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Paresis (1998); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 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.(b)(4).

Event Description

The consumer reported a return of symptoms, specifically nausea.This occurred within 24 hours of a lightning storm/strikes right outside the barn that the patient was in.The tools within the barn had all been electrified.The patient did have 4 programming sessions.It had initially been noticed that the settings had changed.However, all other testing and everything was showing up fine.It was initially thought that the polarity may have been affected.During this time the patient's symptoms gradually got worse and after about a month, the device stopped working completely.The patient was then scheduled for replacement.The revision occurred on (b)(6) 2015.It was stated during the revision that the leads had looked fine.The patient recovered completely.Additional information received from the healthcare provider (hcp) confirmed that this was a complete system replacement due to malfunction.Gastroparesis had come returned.Relevant medical history included gastric stimulation and gastrointestinal/pelvic floor.No follow-up was required.

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 from the hcp reported there was an electrocution with the ins, which needed replacement.The device was replaced as previously noted in the 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5215306
• MDR Text Key: 30969442
• Report Number: 3004209178-2015-22564
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Date Device Manufactured: 11/18/2014
• 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: 15 YR