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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 Kinked (1339)
Patient Problems Overdose (1988); Therapeutic Response, Decreased (2271)
Event Date 12/01/2017
Event Type  Injury  
Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving bupivacaine 6mg/ml at 1. 1350mg/day and morphine 10mg/ml at 1. 892mg/day via an implantable pump. The indications for use were non-malignant pain and chronic low back pain. On (b)(6) 2018 the patient reported that ¿for a few month there i was getting too much morphine and i was going through withdrawals and i was in and out of emergency rooms¿. Per the patient this was within the last 3 months. The patient had surgery about 6 weeks ago because he said he had a ¿kink¿ in his catheter. Per the patient, during this surgery the catheter wasn't replaced, ¿the doctor took the kink out by re-arranging the catheter but didn't replace the catheter¿. No further complications were reported.
 
Manufacturer Narrative
Information references the main component of the system. Other relevant device(s) are : product id: 8780, serial/lot# (b)(4), ubd (b)(6) 2019, udi# (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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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 Key7291586
MDR Text Key100757809
Report Number3004209178-2018-03826
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received03/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/03/2017
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: 02/23/2018 Patient Sequence Number: 1
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