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

Model Number 3116

Device Problem High impedance (1291)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 07/17/2017

Event Type  malfunction  

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

A healthcare provider reported that a patient had a replacement due to battery depletion.After surgery, the therapy impedance was at 505 ohms.The patient's electrode impedance was 400-500 ohms for all leads.They programmed at 2.5 volts with 2<(>&<)>3 combination being used.When the implant was checked on the day of the report, the day after surgery, the impedance was c<(>&<)>2=2495, c<(>&<)>3=252, 2 <(>&<)>3=2294 ohms.It was reviewed that the issue could be dehydration or a connection issue, but was later confirmed that it was more likely a connection issue since the impedance was much higher than expected.The hcp said they would do imaging and they might do an egd.Palpation was discussed, too.The hcp noted they ran impedance at.8, but it sounded like they ran it at the standard default setting.The patient had nausea and vomiting.No further complications were reported.

Manufacturer Narrative

(b)(4).It was clarified via follow up information that the original report was associated with a separate device.This information was captured in the referenced rr.This device, (b)(4), no longer contains a reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the hcp confirmed the device serial number.Please see rr 3004209178-2017-17357.

• 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6722307
• MDR Text Key: 80459711
• Report Number: 3007566237-2017-02935
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

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: 04/28/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 08/14/2017
• Date Device Manufactured: 11/10/2009
• 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 Age: 54 YR
• Patient Weight: 74