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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 Problems Kinked (1339); Aspiration Issue (2883)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
The main component of the device system; the other relevant components include: product id: 8781, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter. 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 fentanyl 2000 mcg/ml for a total dose of 1451. 8 mcg/day, bupivacaine 20 mg/ml for a total dose of 14. 518 mg/day, and morphine 2. 0 mg/ml for a total dose of 14518 mg/day via an implantable pump for spinal pain. It was reported on (b)(6) 2018 a catheter access port (cap) contrast dye study was performed and a catheter kink was noted at the anchor. It was noted that the patient's catheter was intermittently kinking at the anchor point. It was noted the catheter will be revised. The device diagnosis was catheter kink and the clinical diagnosis was increase in pain. The outcome of the vent was noted as ongoing. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was unlikely related. The event date was (b)(6) 2018. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the cause of the catheter kink was not dete rmined. The patient's baseline weight was noted as (b)(6)lbs.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a manufacturer representative. The intrathecal (it) medications were reported as fentanyl (2000mcg/ml at 944mcg/day), bupivacaine (20mg/ml at 9. 5mg/day), and morphine (2mg/ml at 1mg/day). It was reported that the patient had a decrease in pain control. No environmental, external, or patient factors were reported to have caused this issue. As previously reported, a catheter dye study was attempted and the catheter was unable to be aspirated. The catheter was found to be kinked at the anchor spinal side. The spinal segment of the catheter was replaced on (b)(6) 2018, the pump segment was left intact. The issue was said to have been resolved and the patient was "alive - no injury. ".
 
Manufacturer Narrative
The catheter was returned, and analysis observed a kink in the catheter body. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(6) 2018. 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 Key7316291
MDR Text Key101595918
Report Number3004209178-2018-04400
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,Followup,Followup,Followup,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2014
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: 03/06/2018 Patient Sequence Number: 1
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