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

Model Number 37800

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)

Patient Problems Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 02/03/2016

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) 2015, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

The health care provider (hcp) via a manufacturer representative reported that the patient had a return of symptoms of nausea and vomiting.The patient was better versus baseline, but the hcp was concerned with the patient's increasing impedance levels and increase in symptoms.At implant impedance was 420 ohms, the patient was seen on (b)(6) 2016 for recurring nausea and vomiting and their impedance readings were 550 ohms, and on (b)(6) 2016 it was over 900 ohms.At that appointment 2 and case was at 380 ohms, case and 3 was at 784 ohms, and 2 and 3 were at over 900 ohms.The hcp was planning on getting an anteroposterior (ap) x-ray as well as doing an endoscopy to check for lead migration.The hcp was thinking of trying to turn off lead 3 to see how the patient responded.The hcp tried to turn off lead 3 and just use lead 2 and the patient got a shocking sensation when they did that, so they returned back to their previous settings.The hcp was going to scope the patient on (b)(6) 2016 and then determine whether or not to replace 1 lead, both leads, or the whole system including the battery.Before the patient's surgery on (b)(6) 2016, the hcp got an impedance of 560 ohms, which they thought was very odd considering it had been running much higher.The hcp went ahead and replaced the battery and would be sending the old battery back to the manufacturer for review.The patient's impedance was 470 on (b)(6) 2016 and the patient was feeling great after the battery replacement.There was no patient death and the patient recovered without sequelae.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

Event Description

Additional information received from the health care provider (hcp) reported that the cause of the increase in symptoms and impedances was not determined.The battery was changed and the impedances returned to normal and the patient's symptoms improved.The troubleshooting related to the increase in symptoms and impedances was multiple interrogations of the system.The hcp did an esophagogastroduodenoscopy (egd) to rule out erosion of the lead into the stomach lumen.

Manufacturer Narrative

Analysis of the ins (b)(4) found no anomaly.The ins passed functional testing.Normal impedance was measured when tested in saline.The impedance measurement function was also checked at body temperature with fixed 500 ohm resistors connected between the #2, #3 and case electrodes through an extension.The impedance was measured using a clinician programmer after warming 4 hours in a body temperature oven, then 4 days later, and finally 7 days later.The impedance did not change more than 3 ohms in the seven days.No issues were found with the ins impedance measurement function.

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: 5573282
• MDR Text Key: 42520156
• Report Number: 3004209178-2016-07347
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2015
• 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 Age: 00014 YR