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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Overdose (1988); Sedation (2368)
Event Date 11/01/2018
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 clinical study regarding a patient receiving dilaudid (4 mg at 2. 00244 mg/day), bupivacaine (30 mg at 15. 01826 mg/day), and compounded baclofen (200 mcg at 100. 12177 mcg/day) via an implanted pump. The indication for use was malignant pain. It was reported the patient had been excessively sedated since adding baclofen to the concentration of medications and increasing the hydromorphone on (b)(6) 2018. The patient was scheduled for it dose decrease, as provided indicated the patient was likely receiving too much medication. The clinical diagnosis was it medication side effects. It was indicated the event was related to the device or therapy and related to the drugs hydromorphone and baclofen. On (b)(6) 2018, it was noted the side effects had resolved without intervention and no changes were made. The issue resolved without sequelae on (b)(6) 2018. The patient's weight was (b)(6).
 
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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 Key8569367
MDR Text Key143705024
Report Number3004209178-2019-08670
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 health professional,study
Reporter Occupation
Type of Report Initial
Report Date 05/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/14/2019
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 Received04/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/21/2018
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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