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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 Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the patient experienced a shocking sensation.The physician turned down the device stimulation and the patient's symptoms returned.Impedance values were within normal range.The interventions/actions taken were that the device was interrogated.It was unknown if the issue was resolved at the time of the report.
 
Event Description
Additional information was received from a manufacturer representative (rep).In response to the inquiry for if the rep had received additional information, the rep reported that the patient had been experiencing shocking below the ribs, not near the pocket site and that the shocking had been consistent with programming frequency on/off settings.In response to the inquiry for when this issue had been first noticed, the rep replied that an exact date was unknown, but stated that the issue had started a few months ago.In response to the inquiry for what steps were or would be taken to resolve the issue, the rep reported that the patient had been seen by their gi provider and impedances were checked, with all of them being within normal range.The physician lowered the stimulation and the shocking dissipated.They then turned up the stimulation to normal baseline settings and no shocking had occurred.The rep stated that the issue had been resolved at this time and that the device was still in use with no device removal or replacement planned.
 
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.
 
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.
 
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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 Key11530700
MDR Text Key243686352
Report Number3004209178-2021-04607
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/06/2021
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 Date08/28/2021
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/17/2021
Initial Date FDA Received03/19/2021
Supplement Dates Manufacturer Received04/07/2021
04/22/2021
Supplement Dates FDA Received04/21/2021
05/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age32 YR
Patient Weight70
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