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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 Pain (1994)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, lot# n140782018, implanted: (b)(6) 2008, explanted: (b)(6) 2018, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8709sc, serial/lot #: n140782018, (b)(4). Date of event is an estimate. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received via manufacturer representative (rep) regarding a patient who was receiving clonidine (325 mcg/ml, 129. 92 mcg/day)and dilaudid (30 mg/ml, 11. 993 mg/day) via intrathecal drug delivery pump for an unknown indication for use. It was reported that the patient had an increase in pain. There were no known environmental/external/patient factors that may have led or contributed to the issue. At a pump refill (b)(6) 2018, a discrepancy in the expected volume and the actual volume was noted. The expected was 2. 8 ml and there was 7 ml withdrawn. The pump and catheter were explanted and replaced, and would not be returned as the customer discarded them. The issue was resolved and the patient's status was "alive - no injury" at the time of this report. No further complications were reported.
 
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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 Key7445397
MDR Text Key106007899
Report Number3004209178-2018-08447
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,consum
Reporter Occupation
Type of Report Initial
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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 Manufactured08/14/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2018 Patient Sequence Number: 1
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