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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number 37800
Device Problems Intermittent Continuity (1121); Energy Output Problem (1431); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Battery Problem (2885)
Patient Problems Pain (1994); Swelling (2091); Vomiting (2144); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Electric Shock (2554); Swelling/ Edema (4577); Insufficient Information (4580)
Event Date 12/30/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A consumer reported that patient had their device turned off for a non-related surgery, the saturday prior to the report.They stated it was related to the gastroparesis, but not to the device or therapy.The surgery was initially supposed to be on that friday, but the patient had to wait to have someone turn off the implantable neurostimulator (ins).The manufacturing representative (rep) turned the device off, but ever since it had been turned off the patient had been so sick and throwing up bile for days.The consumer had been asking for the rep to turn the ins back on and the hcp said they were "working on it".The consumer stated that the rep had said they were going to try to get the right software for their clinician programmer to turn the device back on, but that had been a week prior to the report.A clinician programmer was being sent to their hcp and was scheduled to arrive the following day.No further complications were reported/anticipated.The patient¿s friend/family member reported that the patient was violently ill because the device was turned off for a surgery.It was also reported that the patient felt like the ins was burning them.No further complications were reported/anticipated.
 
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
Information was received from a consumer regarding a patient with implantable neurostimulator (ins) for gastric stimulation and gast rointestinal/pelvic floor.It was reported the patient had her ins replaced.The patient stated that she was currently in the hospital, and had been in the hospital for 4 months.The patient noted that she had 4 major back to back surgeries, had to stay in the int ensive care unit (icu), and went to the hospital the day after christmas.The patient noted she was currently in the hospital waiting for the healthcare professional (hcp) to come in.The patient reported that she was having a ¿horrible time¿ with the implant.The patient stated her stomach looked like ¿raw meat¿ because the implant had shocked her, burned, or jolted her out of bed, and swelled her stomach.The patient stated the burning was bad at the time of the report.The patient noted the implant had been off and the hcp knew that the needed to be off before the patient underwent surgery.The patient noted the manufacture representative (rep) checked the implant to confirm the implant was turned off.The patient noted she called ¿someone in houston¿ that confirmed that implant was off.The patient noted a week later she was scheduled for surgery, and when the hcp checked the implant the machine ¿dinged¿ and the implant turned on.The patient stated they did not know how it got turned on.The patient stated the reason for her call was to confirm the hcp¿s information and to know if the manufacturer information on the website was correct.Patient services confirmed the hcp¿s information and the website was correct for information related therapies for the manufacturers.The patient reported the warning/risks that the device implant could possibly cause.The patient then read off the warning/risks list and the patient stated that ¿all of the above¿ were happening to them currently, the connection was muffled during this time.Follow up was conducted to clarify this information but was unsuccessful.The patient stated the hcp that knew the patient¿s medical history was out for 4 months.The patient mentioned during the call that the rep for taxes sent the hcp the ¿telemetry box¿ for the patient, the patient then disconnected the call.There were no further complications that have been reported as a result of this event.
 
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.
 
Event Description
Additional information was received from the patient.They reported that they have had to have the stimulator relocated 3 different times during surgeries.They are currently recovering from surgery.They had an ins that "because of surgery flipped in the pocket".Then they rotated it.The patient stated this was related to "the last one" (previous ins).Agent asked for event date and the patient stated "i know that i had it relocated exactly a year from my new date, february of last year".Patient then clarified they had to relocate the ins twice due to it flipping in the pocket.Their managing hcp and the doctor that put current ins in and did relocation of previous ins is in austin at st.David.The patient had "really bad shocking" and the ins was turning on and off and confirmed this was all reported to the manufacturer regarding the shocking and "some serious problems".The patient stated they went into the hospital in (b)(6) 2019 through (b)(6) 2020.The patient also reported they had some "serious pain around the site" and didn't know if this was coming from the stimulator or if this was because the patient had major surgery with "the bowels dying around that area".They were in the hospital for 6 consecutive months.There was no doctor at hospital that was familiar with stimulator at that time and stated now they know the process of how to contact someone to come to hospital to assist.The patient mentioned there was "a recall on some" (agent not clear what the patient was referring to by this).They have reported all of this information to the manufacturer on 4 different occasions.This is why the previous ins was replaced.The patient initially stated previous ins was replaced due to normal battery depletion, but then clarified they "had some problems with one" as noted above and that was reason for replacement.This "might have been" related to the second ins as the patient stated they are not sure if they have had two implants replaced since 2017, but then stated they think they have only had a total of 3 implants (current ins nhx713127h).Reviewed registration information.Agent had a very hard time following the patient throughout call and made best attempt to gather all relevant information.
 
Event Description
Additional information was received from a healthcare provider (hcp).When asked to clarify the report the patient "had some problems with one ," the healthcare provider replied the battery died.
 
Manufacturer Narrative
Note: corrected/added imf codes f11, f15, and f06.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.
 
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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 00777
MDR Report Key7319002
MDR Text Key101864177
Report Number3004209178-2018-04562
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00643169614246
UDI-Public00643169614246
Combination Product (y/n)N
PMA/PMN Number
H990014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/01/2021
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 Date05/28/2018
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/08/2018
Initial Date FDA Received03/06/2018
Supplement Dates Manufacturer Received01/09/2019
06/02/2021
06/09/2021
Supplement Dates FDA Received02/05/2019
06/04/2021
07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
Patient Weight73
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