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

Model Number 3116

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that the patient complained of pain at the device pocket and had less than 50% therapy relief.The physician turned off the device to see if the pain subsides.The patient wants to have the device removed and is going back to the physician soon to assess next steps.It is unknown if any diagnostic testing or troubleshooting was performed.It was reported that the patient status is alive with no injury.It was further reported that the patient did not have a 50 percent or greater symptom reduction.The patient had pain at the stimulator site and eventually they wanted it removed.No troubleshooting was done to provide insight to the issue.The action taken to resolve the issue was removal of the gastric stimulator and generator leads on (b)(6) 2014.The cause of the event was not determined.The patient recovered without permanent impairment.

Manufacturer Narrative

Concomitant products: product id 4351-35, serial # (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead; product id 4351-35, serial # (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead.(b)(4).

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead.

Event Description

Additional information from the patient stated that they had their implantable neurostimulator (ins) removed because it was causing them more pain around the ins site than it was helping them.The therapy was not helping with their nausea anymore, either.Their healthcare provider (hcp) would try to increase stimulation but it didn't help.They ended up turning it off and then removing the system on (b)(6) 2014.The patient also reported that during the removal the hcp had to cut the leads and a portion of the lead and the clips that attach to the spine were left in the body.The hcp told them that it was more trouble than it is worth to removed it and refused to do it.At the time of the report, the patient needed an mri for something completely unrelated to the therapy but had not been able to because of what was left of the system in their body.They did find another hcp that was willing to help take the components out of their body.The patient stated that the notes on their medical history from their old hcp had a lot of discrepancies and did not make sense.They stated there were several midline adhesions and a portion of their liver had adhered to the ins.The patient inquired if that was possible and was referred back to their hcp.

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

Additional information from the hcp stated that the leads were not attached to the patient's spine.The patient had the ins placed on the muscle.She required removal.They could not remove the leads completely from the stomach due to scar tissue and a small amount of the lead was left on the stomach wall.

Manufacturer Narrative

Evaluation of the implantable neurostimulator (ins) determined there were no issues with the ins can and telemetry was acceptable.Good stable output was observed and it was indicated that no anomalies related to the reported event were observed.Evaluation of the leads determined the conductors were broken in the body of the lead.The distal end was not returned, confirming the allegations reported in the event.Good stable output was observed on the leads.Evaluation code result apply to leads: product id: 4351-35, serial# (b)(4), and product id: 4351-35, serial# (b)(4).Evaluation code conclusion applies to leads: (b)(4) and (b)(4) evaluation codes apply to the device serial number (b)(4).Evaluation code conclusion applies to device serial number (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation (b)(4) is applicable to lead 4351-35 (b)(4) and lead 4351-35 (b)(4) after further review, it was determined that evaluation (b)(4) is no longer applicable to the event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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 NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 4341136
• MDR Text Key: 5200687
• Report Number: 3004209178-2014-24216
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/08/2023

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: 06/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 11/10/2017; 01/03/2018; 01/09/2018; 11/08/2023
• Supplement Dates FDA Received: 02/20/2017; 03/20/2017; 12/08/2017; 01/09/2018; 02/01/2018; 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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 Sex: Female