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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 Problems Device Alarm System (1012); No Audible Alarm (1019); Pumping Stopped (1503)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 09/08/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving unknown drugs via intrathecal infusion pump for non-malignant pain.It was reported that the patient had good and bad days with their pain.It was reported that yesterday (b)(6) 2020) the patient was in a lot of pain and 2-3 days prior.It was reported that the caller went to use the ptm yesterday and saw an 8476 code on screen.The critical alarm was not heard but the alarm bell icon could be seen on screen.The code was reviewed, and it was suggested the patient contact their hcp to have the pump read.It was stated that the hcp was 3 hours away and closed on fridays.
 
Event Description
Additional information was received from the consume via a device manufacturer representative indicated that the pump logs were read and a stall was confirmed.It was reported that replacement is scheduled for (b)(6) 2020.
 
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.
 
Event Description
Additional information was received from a company representative (rep) indicated the pump was replaced on (b)(6) 2020 and the rep would be sending it back for analysis.
 
Event Description
Additional information was received via a healthcare provider.The motor stall had not resolved.At the time of the event, the patient¿s pump administered fentanyl 500 mcg and bupivacaine 15 mg.They were unsure of the cause of the motor stall.The patient was given dilaudid, 4 mg tablets, until the replacement date.The pump was replaced.The pump was returned to the manufacturer for analysis.
 
Manufacturer Narrative
H3: analysis of the pump revealed a motor gear train anomaly regarding corrosion and/or wear and/or lubrication; stall was due to gear wheel number 3.Regarding gear number 3, analysis noted corrosion on the surface with teeth partially or completely corroded.As per the logs, the pump administered fentanyl (concentration: 500.0 mcg/ml, dose rate: 90.05 mcg/day) and bupivacaine (concentration: 15.0 mg/ml, dose rate: 2.702 mg/day) as of 2020-aug-25.The device code c63033 was previously applied in error and was replaced with c63310.The patient code c50526 was not previously added in error.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 Key10534450
MDR Text Key206941222
Report Number3004209178-2020-15932
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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,Followup
Report Date 10/15/2020
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 Date01/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received09/15/2020
Supplement Dates Manufacturer Received09/13/2020
09/18/2020
10/13/2020
Supplement Dates FDA Received09/16/2020
09/22/2020
10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age84 YR
Patient Weight70
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