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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Erosion (1750); Erythema (1840); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)
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 patient who was receiving baclofen, dilaudid, and an unknown heart medication via an implantable pump for non-malignant pain and failed back surgery syndrome.On (b)(6) 2020, it was reported that the patient's pump pocket keeps blistering and the pump starts to come out of their body.According to the patient, their body was "rejecting the pump". the patient reportedly had surgery on the pump 3 months ago to "clean everything up".This was the fourth time the patient's healthcare provider had to "go in" and perform such a procedure.The patient noted that they had been dealing with this issue for almost 2 years.
 
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 healthcare provider indicated that a pump revision occurred on (b)(6) 2020 due to the lesion.It was reported that the patient was evaluated in the office on (b)(6) 2020 and the lesion was painful to touch, red, puffy and eliptical in nature.It was reported that there was s surgical scar and that the pump was eroding through the patient's skin.The patient was referred to a general surgeon for further evaluation of his symptoms.
 
Event Description
On (b)(6) 2021, information was received from a manufacturer representative (rep).The rep reported they were at the pump replaceme nt case and the catheter was also being revised.Programming and additional information regarding catheter volume was reviewed.Additional information stated the patient reported that they had gone in 4 times and the rep stated the hcp told them they went one time, one month ago and the hcp cleaned and sewed it shut.The rep stated that the hcp reported the patient called him the last couple of days and said there was a hole.The rep stated that the general surgeon removed the old pump today (b)(6) 2021 and reported that there was a lot of granulation.The rep stated that there was clearly something that looked like a blistering on the top of the pump pocket, which the hcp called "dehiscence" and the general surgeon said it was "granulation".The rep stated she did see that there was definitely a hole.The previous pump was on the right so they made a new pocket of the pump to the other side and tunneled and connected a new catheter.The general surgeon removed the old pump and part of the old catheter.On 2021-jan-14, additional information reviewed the patient was brought back and was doing great.Additional programming information was reviewed.
 
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
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10979489
MDR Text Key220642176
Report Number3004209178-2020-21522
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630505
UDI-Public00643169630505
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/14/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight91
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