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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 Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978); Mechanical Jam (2983)
Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 08/26/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The implant date of the catheter was stated to be (b)(6) 2017, although this was interpreted as the date the new catheter was implanted. Pump logs would be returned with the pump, which was stated to be sent for return on 2017-sep-01. The representative did not know if the stall recovered. It was reported the cause of the catheter leak was that the catheter was damaged and there was a small rupture. The catheter would not be returned.
 
Manufacturer Narrative
Analysis identified no anomalies with the pump. Eval -conclusion updated. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The main component of the device system; the other relevant components include: product id: 8784, lot#: 0213238593, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The implant date of the catheter was (b)(6) 2017. The catheter was still in use; only the connection to the pump was replaced because the hcp saw a little rupture in the pump segment.
 
Manufacturer Narrative
Other relevant components include: product id 8784 lot# 0213238593 serial# implanted: explanted: (b)(6) 2017 product type catheter. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving lioresal (500 mcg/ml at 25 mcg/day) via an implantable pump for an unknown indication for use. It was reported that the patient had an mri on (b)(6) 2017. The patient's symptoms then returned, and the pump had no effect anymore. A catheter study was performed, revealing leakage of the catheter connection to pump. The patient went in for a catheter revision to replace the pump segment on (b)(6) 2017. The representative interrogated the pump and saw the message "motor stall occurred" on (b)(6) 2017, and "stopped pump period may exceed tube set" on (b)(6) 2017. The pump had not been checked after the mri to see if it had restarted. The pump was also replaced along with the pump segment. The issue was resolved, and the patient status was alive - no injury. The products would be returned. No further complications were reported or anticipated.
 
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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 Key6838205
MDR Text Key101188480
Report Number3004209178-2017-18598
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2016
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: 09/01/2017 Patient Sequence Number: 1
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