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

Model Number 3116

Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Electric Shock (2554)

Event Date 09/06/2016

Event Type  malfunction  

Event Description

The consumer reported that every once in a while their implant was shocking them over the last week since (b)(6) 2016.About 3 days ago, the patient experienced shocking 3 or 4 times in 1 day and experienced constant shocking yesterday, probably about 20 to 30 times a day.The patient could not reach their health care provider (hcp) due to the time difference.There were no trauma or falls that could be related to the issue as the patient had parkinson¿s disease and hadn¿t fallen for at least 6 to 7 weeks.The patient had other issues and had a transient ischemic attack (tia) on (b)(6) 2016.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

Manufacturer Narrative

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

Manufacturer Narrative

Information references the main component of the system and the other applicable components are: product id (b)(4) serial# (b)(4): product type lead product id (b)(4) serial# (b)(4): product type lead patient code (b)(6) and device code (b)(4) apply to the ins.Patient code (b)(6) and device code (b)(4) apply to the leads.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer (con).It was reported that the patient had some issues with their device in the past.The patient was feeling a shocking pain in hawaii and had to have the device replaced.During the surgery, one of the leads broke off and went into their liver.The patient passed during the surgery for 6 minutes and was brought back, noting that it took blood and plasma to bring them back.There were no further complications 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: 5999968
• MDR Text Key: 56539639
• Report Number: 3004209178-2016-20448
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2018

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: 02/14/2015
• 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: 09/13/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: 09/13/2016; 11/01/2016
• Supplement Dates FDA Received: 09/26/2017; 01/18/2018
• Date Device Manufactured: 08/21/2013
• 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): Life Threatening
• Patient Age: 66 YR