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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Overdose (1988)
Event Date 04/06/2018
Event Type  Injury  
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 device manufacturer representative regarding a patient receiving fentanyl(17. 504 mg/day, 25. 0 mg/ml), marcaine(3. 509 mg/day, 5. 0 mg/ml), dilaudid (17. 504 mg/day, 25. 0 mg/ml) and ketamine(14. 003 mg/day, 25. 0 mg/ml) via an implantable infusion pump for the treatment of non-malignant pain. The old drug before the concentration change was fentanyl(17. 504 mg/day, 25. 0 mg/ml), marcaine(3. 509 mg/day, 5. 0 mg/ml), dilaudid (17. 504 mg/day, 25. 0 mg/ml) and ketamine(14. 003 mg/day, 20. 0 mg/ml). It was reported that the patient experienced labored breathing following a refill. A concentration change and bridge bolus was programmed by the nurse. It was noted that narcan was administered. The issue was resolved and patient status was alive with no injury at the time of the report. No further complication was 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 Key7406682
MDR Text Key104676788
Report Number3004209178-2018-06730
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
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2016
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 Received04/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/01/2015
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: 04/09/2018 Patient Sequence Number: 1
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