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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675)
Patient Problem Muscular Rigidity (1968)
Event Date 05/02/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8709, serial# (b)(4), implanted: (b)(6) 1999, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received via manufacturer representative from a patient who was receiving gablofen (1215 mcg/day, 2000 mcg/ml) via intrathecal drug delivery pump for intractable spasticity and other spasticity. It was reported that irregular refill amounts occurred, varying from 6-9 ml, over the "last couple" refills, and the patient was experiencing increased spasticity. It appeared that the catheter was occluded. Attempted catheter access produced good flow, and x-rays did not show any breaks or fractures. No interventions were taken to resolve the issue; it was unknown whether surgical intervention was planned. The issue was not resolved and the patient status was "alive - no injury" at the time of this report. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional via manufacturer representative. It was reported that it was unknown whether surgical intervention was expected or planned. The product had not been explanted. The actual and expected residual volumes were unknown. No further complications were reported.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7490913
MDR Text Key107749996
Report Number3004209178-2018-10245
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received05/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/18/2013
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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