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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 8637-40
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Overdose (1988); Sedation (2368); Decreased Respiratory Rate (2485); No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8551, lot#: unknown, product type: accessory.Product id: 8551, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving an unknown intrathecal drug via an implantable infusion pump.It was reported on (b)(6) 2020 that the hcp thought the refill kits with the component changes were unsafe compared to the previous refill kits, and that the hcp thought they had a recent pocket fill caused by the new refill kit.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received in response to a request for follow-up.It was reported that the drug involved with the reported event was fentanyl 3000 mcg/ml at a dose of 900 mcg/day, bupivacaine 30 mg/ml at a dose of 9 mg/day, and clonidine 600 mcg/ml at a dose of 180 mcg/day.It was also confirmed that no programming changes (other than the reservoir volume) had been made at the refill.
 
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 hcp via a manufacturer representative in response to a request for follow-up.It was reported that about 1 hour post-pump refill on (b)(6) 2020, the patient was found in the hospital lobby sedated with decreased respirations.The patient was taken to the er and received one dose of narcan.The pain clinic was contacted, the pump was assessed for pocket fill, but it was found to have all 40 ml still in the pump.On examination of the refill tubing, it appeared the clamp had slipped off the tubing prior to the needle being removed from the port during the initial pump refill.Per the hcp, the assumption was that a droplet of medication was leaking during the needle removal due to the clamp failure.It was indicated that the refill was "incident-free" during the initial refill process, with no difficulty accessing the refill port or withdrawing medications during the procedure.It was stated that the hcp did not deem this a pocket fill.
 
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 MN 00777
MDR Report Key9950286
MDR Text Key190814759
Report Number2182207-2020-00125
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,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 06/26/2020
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 Date03/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/07/2020
Initial Date FDA Received04/10/2020
Supplement Dates Manufacturer Received04/14/2020
04/29/2020
06/26/2020
Supplement Dates FDA Received04/21/2020
04/29/2020
06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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