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

Model Number 37800

Device Problems Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Nausea (1970); Pain (1994); Seroma (2069); Burning Sensation (2146)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) and manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient was having pain post operation.The hcp stated the patient had heat, hot burning pain.The hcp noted the impedances were normal, 300-510 ohms range, the patient was using 2 and 3 electrodes for programming.The hcp stated the burning sensation went away when the therapy was off.The patient had nausea when the implant was off, and it went away when therapy was turned back on.It was reviewed by technical services that even though it was "general" highly unlikely for an ins to have fluid short, technical services suspected that might be the case.The hcp did not think there was anything wrong with the pocket site in terms of a potential infection.It was noted the onset of the burning hot pain was sudden.Additional information from the hcp on (b)(6) reported imaging showed some fluid at the pocket site.Additional information from the rep reported the hcp was talking about replacing the ins on (b)(6) since the patient was still hospitalized.It was discussed not dropping the new ins in antibiotics solution prior to implant, the rep was unsure if that was done in the case.The rep noted the hcp was fairly new to implanting.The rep would be sending the hcp a return mail kit to return the ins.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the healthcare professional (hcp) on november 13th reported on (b)(6) 2018 the patient had burning pain, increasing prevalent ceased when the device was turned off.The hcp noted it was not shocking pain and impedance registered in the 300-500s, consistent with no lead structural damage.It was noted the device was removed due to a malfunctioning device.The hcp noted the patient just had pain.There was no patient death and the patient recovered without sequela.The hcp noted the patient¿s settings was 4v, the impedances were 300¿s cm-1, cm-2, 500 2-3.The hcp noted it was cycling off time 4.It was noted the implantable neurostimulator (ins) was explanted on (b)(6) as a generator exchange on (b)(6) 2018.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Event Description

Additional information from the manufacture representative (rep) reported the issue was overheating and it happened in december.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Event Description

Additional information from the manufacture representative (rep) reported the day of explant was (b)(6), 2018.Additional info rmation from the healthcare professional (hcp) reported the device was explanted on (b)(6), 2018.This information is contradicting to previously reported information.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• MDR Report Key: 8050761
• MDR Text Key: 126522850
• Report Number: 3007566237-2018-03256
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2019

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: 11/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/13/2018; 02/05/2019; 02/13/2019; 03/07/2019
• Supplement Dates FDA Received: 11/27/2018; 02/14/2019; 02/22/2019; 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 18