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

Model Number 3116

Device Problems Break (1069); Disconnection (1171); Unstable (1667); Low Battery (2584); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Twiddlers Syndrome (2114); Vomiting (2144); Cramp(s) (2193); Discomfort (2330)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, 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

On 2016-10-12 a consumer via a representative reported the consumer was looking for a smaller, more comfortable gastric stimulation system as the one she had was very uncomfortable and very painful.On 2016-nov-29, additional information received from the consumer reported that for the last six months she had been getting awful pain.The consumer went to see her doctor a week ago yesterday.The doctor said it wasn't reading properly and that possibly one of the wires came unhooked, or wasn't transmitting properly and that was why she was having pain.She said the doctor told her she could hot wire it and could do different signals on the wires and would have to implant a different device.She reprogrammed it on (b)(6) 2016 and she said she would feel a tingle here and there.Then she told her she couldn't replace the device until (b)(6) 2017.The consumer said she left the doctor¿s office and went down the stairs to get the car and she got a hideous stomach cramping.She said you could see it through her clothing and it was painful.She went back upstairs to see the doctor.The doctor said the only option was to turn the stimulation off, so she turned it off.Now since it has been off the consumer was so nauseous and was in pain since it had been off.The consumer had been vomiting several times a day.The consumer said several years ago she had an ultra sound and found out she had four hernias.So she went back to that doctor to see if she had hernia's again and she doesn't.She went back to her primary care doctor.The consumer noted she could not wait until (b)(6) to get her device replaced.Further information received from a manufacturer representative reported a lead break.The battery was low and impedance was not available.During the battery replacement on (b)(6) 2016, it was discovered that the implanted leads were twisted into one braid, broken, and disconnected from the implant site.The battery was flipped and upside down in the pocket.Factors noted to have led to the event included that it appeared the device was being manually manipulated ¿ twiddler.It was unknown if any troubleshooting was done.The twisted leads were explanted and replaced with a new system.The issue was noted as resolved.

Manufacturer Narrative

(b)(4) is no longer applicable to this event.

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; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6210112
• MDR Text Key: 63412667
• Report Number: 3004209178-2016-27313
• 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: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Date Device Manufactured: 06/07/2011
• 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: 65 YR