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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 8637-20
Device Problems Kinked (1339); Material Integrity Problem (2978)
Patient Problem Overdose (1988)
Event Date 12/26/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8711, serial# (b)(4), product type: catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), ubd: , udi#:. 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 gablofen (2000 mcg/ml at 900 mcg/day) via an implantable infusion pump. It was reported that during a pump replacement surgery due to normal battery depletion, the catheter was found to be fractured. The caller stated that the healthcare provider (hcp) said that the catheter was kinked and he resolved it with a repair kit. It was reported that the medication was put at the pre-surgical rate, but that the patient was overdosed due to having had the catheter problem. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
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)
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 Key7592021
MDR Text Key110767568
Report Number3004209178-2018-13201
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 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2012
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 Received06/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2011
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: 06/12/2018 Patient Sequence Number: 1
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