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

Model Number 37800

Device Problems High impedance (1291); Device Contamination with Chemical or Other Material (2944)

Patient Problems Dehydration (1807); Headache (1880); Nausea (1970); Seroma (2069); Vomiting (2144); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Abdominal Cramps (2543)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, 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

The consumer and the health care provider (hcp) via a manufacturer representative reported that the patient was having a rough week and their device needed to be turned up.The patient was reimplanted with 2 leads and a battery on (b)(6) 2016.The patient had been experiencing a lot of nausea and vomiting since their surgery.When the hcp checked the patient's device on (b)(6) 2016, they found that their impedance was out of range.Case and 2 was at 300 ohms, case and 3 was greater than 20,000 ohms, and 2 and 3 were greater than 20,000 ohms.It was unknown if there were any environmental, external, or patient factors that may have led to the event.The troubleshooting performed was a programming check with the clinician programmer.The hcp was going to take the patient into the operating room on (b)(6) 2016 and was going to see if it was just a set screw that was causing the impedance issues.If not, the hcp planned on trying to replace the battery.The hcp opened the patient's pocket and the leads were in front of the battery and there was quite a bit of serous fluid in the pocket as well.The hcp removed both leads and wiped them off and there was some fluid on the leads.After the hcp placed the leads back into the battery and tightened the set screws they took another impedance check.Case and 2 was approximately 292 ohms, case and 3 was approximately 293 ohms, and 2 and 3 was 390 ohms.All was well once again.

Event Description

Additional information received from the consumer reported that the patient first started experiencing the issue with a rough week and the device needing to be turned up after they had surgery on (b)(6) 2016.It had been hard to function with it not being turned up.The patient was throwing up, 8 to 10 times daily.The patient couldn't sleep at night because of nausea and had cramping in the stomach.The patient had vomiting, headache, back ache, was restless, and was miserable.There was no activity change that led to the issue and the pacer worked better on high setting for them.The step taken to resolve the rough week was that the patient went to the emergency room (er) to get fluids and had dehydration.The issue had not been resolved and the patient would go to their health care provider (hcp) on "friday" to get an adjustment.

Manufacturer Narrative

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

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5660014
• MDR Text Key: 45314692
• Report Number: 3004209178-2016-09630
• 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
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2016
• Date Device Manufactured: 02/18/2016
• 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: 51 YR