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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 Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675)
Patient Problem Swelling (2091)
Event Date 04/24/2018
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 healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine 10 mg/ml; 4 mg/day and via an implantable pump. The pump was previously delivering hydromorphone 10 mg/ml; 4. 7 mg/day. Indication for use was spinal pain. The date of the event was (b)(6) 2018. It was reported the pump had a volume discrepancy. The actual residual volume (arv) 22 ml was less than the expected residual volume (erv) 32 ml. There were no known discrepancies noted on past refills. The patient experienced feet swelling. The clinician programmer was used to update the pump. 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 from a healthcare professional (hcp) via a manufacturer representative. The physician attempted a standard refill procedure. They will bring the representatives team to the next refill appointment to help troubleshoot. The cause of the volume discrepancy was not determined. It was unknown if the volume discrepancy and feet swelling had been resolved. The patient¿s weight at the time of the event was unknown. Medical history was not available.
 
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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 Key7469106
MDR Text Key106849963
Report Number3004209178-2018-09478
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
Type of Report Initial,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received04/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/23/2015
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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