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

Model Number 3116

Device Problems High impedance (1291); Unstable (1667); Impedance Problem (2950); Material Deformation (2976); Positioning Problem (3009)

Patient Problems Calcium Deposits/Calcification (1758); Nausea (1970); Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id 435135, serial # (b)(4), implanted: (b)(6) 2010, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2010, product type lead.

Event Description

A manufacturing representative reported on behalf of the healthcare provider (hcp) office that they saw a patient and stated the patient complained that they felt the battery was flipping or moving around in the pocket.They were not experiencing any pain and their symptoms were being controlled.Impedance was taken and 2403, which was out of range for.And c was over 2000.And c were well within range.It was unclear what led to the event.The hcp was going to order an x-ray and refer to the implanting physician.It was noted that the issue was not resolved at the time of the report.Follow up from the rep indicated that they had no new information available.The implantable neurostimulator (ins) was indicated for gastric stimulation/gastrointestinal/pelvic floor.

Event Description

Additional information received reported the impedance reading was >800 ohms and the patient experienced an increase in nausea.The healthcare provider was attempting to get an approval from her carrier to replace both of the leads as well as the battery on (b)(6) 2017.

Event Description

Additional information from the rep reported the patient was schedule for a battery change and a possible lead revision on (b)(6) 2017.

Event Description

Additional information from the rep reported that the patient had the device removed on (b)(6) 2017.There was an impedance issue with lead 2, c<(>&<)>2 was about 2500.New leads and battery were implanted.The leads had become twisted in a couple of locations where the calcium deposits were covering the knots in the leads.It may have been due to the patient flipping the battery in the pocket.

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.

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 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6256432
• MDR Text Key: 64974314
• Report Number: 3004209178-2017-01006
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Date Device Manufactured: 10/02/2012
• 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: 42 YR