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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 Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Insufficient Information (3190)
Patient Problems Internal Organ Perforation (1987); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2020, product type: lead, product id: 435135, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 21-jan-2013, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 21-jan-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that there was a ¿check ins clock¿ on the clinician programmer.The patient was in severe pain and they were doing well 7-10 days prior to the report.It was noted that it looked like a possible lead sticking up on the esophagogastroduodenoscopy (egd), but it was submucosal.Additional information was received from the hcp via the rep.It was reviewed that the ins and clinician programmer were off by one hour.Additional information was received from the manufacturer representative (rep).The patient¿s identifying information was provided.It was reported that they were not sure what the cause of the ¿check ins clock¿ message was even after confirming with the healthcare professional (hcp).The rep instructed the hcp how to correct the time in the ins but they did not have confirmation that this was done.An egd was performed and there was evidence of lead migration in the stomach.They did not know what caused it.The patient was referred to a different hcp who replaced both leads and ins on (b)6) 2020.The patient was doing much better.No further patient complications were reported as a result of this event.
 
Manufacturer Narrative
Continuation of d11: product id: 435135; lot#serial#: (b)(6); implanted: on (b)(6); explanted: on (b)(6) 2020; product type: lead; product id: 435135; lot#serial#: (b)(6); implanted: on (b)(6) 2011; explanted: on (b)(6) 2020; product type: lead.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.
 
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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 Key9857403
MDR Text Key184201961
Report Number3004209178-2020-05745
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
Report Date 04/14/2020
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 Date12/28/2018
Device Model Number37800
Device Catalogue Number37800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/28/2020
Initial Date FDA Received03/19/2020
Supplement Dates Manufacturer Received04/14/2020
Supplement Dates FDA Received04/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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