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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 Electromagnetic Interference (1194); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2020
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 healthcare provider via manufacture representative regarding a patient receiving unknown drug via an implanted infusion pump. It was reported the patient's pump did not recover after waiting 2 hours after the mri. The caller stated the patient had since gone home and the office was closed. Tech services recommended having the patient follow-up with the physician on monday. It was noted the pump was at minimum rate mode. No symptoms were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via pump session reports. Review of the reports determined that the motor stall event no longer appeared in the logs because the pump had been updated multiple times. The logs, by design, have a 30 entry capacity so the motor stall entry had dropped off as would be expected. There was no issue with regards to the logs. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via the pump logs. The pump logs dated (b)(6) 2020 showed a motor stall occurred on (b)(6) 2020 at 12:08 pm. The pump logs dated (b)(6) 2020 showed the pump motor stall recovery on (b)(6) 2020 at 3:26 am. The last entry showing on the logs was dated (b)(6) 2020 at 1:39 pm which was after the stall that occurred at 12:08 pm. The pump was delivering fentanyl (8,000 mcg/ml at 50 mcg/day), hydromorphone (6 mg/ml at 0. 0375 mg/day) and bupivacaine (15 mg/ml at 0. 094 mg/day) at the time of the event. No further complications have been reported as a result of this event.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10042762
MDR Text Key190541092
Report Number3004209178-2020-08364
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2016
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 Received05/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/11/2015
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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