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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 Volume Accuracy Problem (1675)
Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)
Event Date 04/16/2018
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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving compounded baclofen (unknown concentration and dose) via an implantable pump for an unknown indication for use. It was reported that on (b)(6) 2018, the volume reported by the n'vision was less than the volume aspirated. The patient experienced underdose symptoms and a small reduction in the effect of therapy. The hcp was still studying this volume difference and had requested the presence of medtronic at the next refill that would occur approximately 15 days from (b)(6) 2018. Actions taken were continued study by medical staff and medtronic, as reported. It was reported there were no contributing factors to the event. The pump remained implanted and in service. The issue was not resolved. The patient status was alive - no injury. No medical or surgical intervention was needed, the event did not lead to or extend hospitalization, and there was no injury as a result of this event. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. Apparently there was no problem with the patency of the catheter. The pump rotor had normal operation. They were trying to identify the cause of the volume discrepancy. The last refill was carried out on (b)(4) 2018. The pump did not show any difference of aspirated volume and informed volume. They would follow at the next two refills. No actions were taken, they just performed the refill according to manufacturer guidelines. They would follow the next steps in order to ensure that everything happens well.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative indicated the residual volumes at the (b)(6) 2018 refilled included an expected reservoir volume (erv) of 11,9ml and an actual reservoir volume (arv) of 11,18ml. The representative confirmed that the reported volumes were correct.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7499159
MDR Text Key107753687
Report Number3004209178-2018-10457
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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