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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 Problem Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2018
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 provider via a manufacturing representative (rep) regarding a patient receiving an unknown dose and concentration of baclofen via an implantable pump for intractable spasticity and head/brain injury. It was reported there was an 8-9 milliliter (ml) volume discrepancy between the expected reservoir volume and the collected reservoir volume at a refill in (b)(6) 2018. It was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue. Regarding diagnostics/troubleshooting performed, it was unknown if any diagnostics or troubleshooting had been performed, however a dye study was planned. It was indicated no interventions/actions had been taken to resolve the issue and the issue had not been resolved at the time of the report. Surgical intervention had not occurred and was not planned. The patient¿s status at the time of the report was provided as ¿alive-no injury. ¿ no further complications were reported or anticipated. Other medications being taken at the time of the event were unknown. The patient¿s weight and medical history were also unknown.
 
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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 Key7440887
MDR Text Key105900178
Report Number3004209178-2018-08330
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2015
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 Received04/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/27/2014
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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