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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); Material Integrity Problem (2978)
Patient Problem Muscular Rigidity (1968)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 8780, 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 manufacturer representative regarding a patient who was receiving gablofen (2000mcg/ml at 325mcg/day) via intrathecal drug delivery pump. The indication for use was not noted. It was reported that the patient experienced increased spasticity symptoms. No environmental, external, or patient factors were reported to have caused this issue. The hcp opened the pump pocket and found the catheter appeared to be tightly wrapped and kinked. After performing adhesiolysis in the pump pocket, he was able to easily aspirate the catheter. At the physician's discretion, the pump was replaced even though it was not quite ready for end of service (eos). 7ml of clear cerebrospinal fluid (csf) was easily aspirated prior to replacing the pump. Then, after replacing the pump, the hcp again successfully aspirated 0. 5ml of clear csf from the catheter access port (cap) of the new pump. The issue was said to have been resolved and the patient was "alive - no injury. " there were no further complications reported at this time.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative. It was reported that the physician felt that he found the problem to reside with the catheter. The pump never alarmed and gave no indication that it was a part of the problem. The pump was not at end of service life but the physician replaced it because it made sense to do it then. There were no further complications reported at this time.
 
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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 Key7496587
MDR Text Key107687978
Report Number3004209178-2018-10410
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
Report Date 05/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2016
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 Received05/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/19/2014
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: 05/08/2018 Patient Sequence Number: 1
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