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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 3116
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Nausea (1970); Staphylococcus Aureus (2058); Vomiting (2144); Peritonitis (2252); Skin Inflammation (2443); Fluid Discharge (2686)
Event Date 06/15/2018
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) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient was getting peritoneal dialysis in (b)(6) 2018.It was noted at some point in (b)(6) 2018 the patient reported to a medical center with peritonitis, fluid in the abdomen.It was noted the patient test positive for a staph infection, the patient then transitioned to hemodialysis.The patient presented to the hcp¿s office in (b)(6) 2018 with worsening symptoms of nausea and vomiting.The hcp adjusted her setting at that time.The patient then presented to the hcp¿s office in (b)(6) 2018 with blistering and drainage at the battery pocket site.The patient was put on oral antibiotics, cipro and "batrum", for prolonged use as the patient was refusing to have her battery and leads removed.It was noted the issue was not resolved at the time of the report.It was noted there was no surgical intervention and surgical intervention was not planned.The patient was listed as alive with no injury at the time of the report.There were no further complications that have been reported as a result of this event.
 
Manufacturer Narrative
Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative (rep).It was reported that the patient was seen on (b)(6) 2020 in the hcp office.The infection was around their pocket site.It was noted that the patient hadn't been good at following up with the hcp due to the patient not wanting the device removed.
 
Manufacturer Narrative
Patient code (b)(4) no longer apply.Updated as life threatening no longer applies.
 
Manufacturer Narrative
Continuation of d11: product id 4351-35, serial# (b)(6), implanted: (b)(6) 2014, explanted: product type lead, product id 4351-35, serial# (b)(6), implanted: (b)(6) 2014, explanted: 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.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
It was stated that the patient had their device removed on (b)(6) 2020.
 
Event Description
Additional information received from a manufacturer representative (rep).It was reported that the patient is having her device removed on (b)(6) 2020.No further complications were noted or anticipated.
 
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 Key8103424
MDR Text Key128333898
Report Number3004209178-2018-26227
Device Sequence Number1
Product Code LNQ
UDI-Device Identifier00643169174993
UDI-Public00643169174993
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,Followup,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/28/2015
Device Model Number3116
Device Catalogue Number3116
Was Device Available for Evaluation? No
Date Manufacturer Received06/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age52 YR
Patient Weight99
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