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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); Insufficient Flow or Under Infusion (2182)
Patient Problems Fatigue (1849); Itching Sensation (1943); Muscular Rigidity (1968)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a company representative who reported that there was no additional information regarding the cause of the volume discrepancy. The managing physician was going to note any discrepancies on the next refill date and report if there were any issues.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (2000 mcg/ml at 309. 5 mcg/day) via an implanted pump. The indication for pump use was intractable spasticity. It was reported that per the managing practice, the pump was empty when performing the scheduled refill on (b)(6) 2021. The expected volume was 15. 2 ml; however, when they tried to pull the drug from the pump it was empty. The patient complained of itching, tiredness, and increased spasticity prior to coming in for the refill. The pump was refilled that day and no changes were made to the pump settings. The patient¿s symptoms eventually went away. A dye study was ordered and performed on (b)(6) 2021. The dye study was successful. There were no issues. An mri was performed on (b)(6) 2021 and those results were unknown. It was noted that the patient normally came in on ce very 6 months for refills. According to the pump logs, there was an update done on (b)(6) 2020, but what exactly was done on that date was unknown. The refill prior to that was (b)(6) 2020. The issue was noted to be resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the 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 Key12157684
MDR Text Key262180325
Report Number3004209178-2021-10720
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 07/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2017
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 Received07/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/14/2015
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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