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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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MDT 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 Therapeutic Response, Decreased (2271); Sweating (2444); Sleep Dysfunction (2517); Underdose (2542); Ambulation Difficulties (2544)
Event Date 05/24/2020
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 foreign consumer via a manufacturer representative regarding a patient who was receiving morphine at an unknown concentration and dose via an implantable infusion pump.It was reported that the patient reported a loss of therapy with consequent underdosing/underdose symptoms.It was indicated that any factors that may have led or contributed to the event were ¿n.A.¿ the patient was hospitalized to receive medication and the issue was resolved.At the time of the report, the patient status was alive without injury.No further complications were reported 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.
 
Event Description
Additional information was received from a foreign consumer via a manufacturer representative.It was reported that the pump was del ivering morphine 10,0 mg/ml at 2,097 mg/day.The patient first start experiencing the reported loss of therapy/underdose symptoms on (b)(6) 2020 around 22:00.During the night, the patient also experienced sweating and nightmares.On (b)(6) 2020, the patient was u nable to leave the bed.The patient was sure of the symptoms but was also sure that the pump had two more days of medicine (to reserve 2 ml).On (b)(6) 2020, the patient went in for a refill, and the doctor confirmed ¿it could be abstinence¿.[the hcp] checked the battery replacement date; (b)(6) 2021.By the end of the day on (b)(6) 2020, the patient was better.On (b)(6) 2020, the patient woke up with no sign of abstinence.The cause of the patient¿s symptoms was notyet determined.The pump was implanted in 2014.
 
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 a foreign consumer via a manufacturer representative.It was reported that at the patient¿s (b)(6) 2020 refill, the actual reservoir volume (arv) was 0,5 ml, and the expected reservoir volume (erv) was 2,0 ml.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
MDR Report Key10105539
MDR Text Key193083232
Report Number3004209178-2020-09454
Device Sequence Number1
Product Code LKK
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 06/11/2020
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? No
Device Operator Health Professional
Device Expiration Date05/28/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/28/2020
Initial Date FDA Received06/01/2020
Supplement Dates Manufacturer Received06/02/2020
06/08/2020
Supplement Dates FDA Received06/06/2020
06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age54 YR
Patient Weight64
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