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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 863740
Device Problems Filling Problem (1233); Kinked (1339); Volume Accuracy Problem (1675)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pocket Erosion (2013); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a consumer regarding an implantable intrathecal pump intended to deliver dilaudid and an unknown type of baclofen (concentration and doses unknown), indicated for non-malignant pain ad lumbar radiculopathy. It was noted that the reason for the call was to get a list of implanting physicians. The patient initially stated that he ¿used to have one,¿ but he had to get the pain pump taken out about five years ago. The patient reported that when he had his second pump, an actual intern who was trying to find the pump¿s port had ¿stuck the patient so many times¿ that it got infected. It was stated that it got infected around the scar line and the pump pushed itself out. The event date was unknown. When asked when the issue occurred, the patient reported that the only thing he could say was that it came out on thanksgiving day, about six years ago. No further complications were reported or anticipated.
 
Manufacturer Narrative
Product id: 8709, lot# l72976, implanted: (b)(6)2000, explanted: (b)(6)2012, product type: catheter, product id: 8575, lot# n275096, implanted: (b)(6)2011, explanted: (b)(6)2012, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: l72976, drs-ls8709. Patient code (b)(4) and device code (b)(4) no longer apply. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) on 2018-apr-30. Per the hcp, no infection was found. It was reported that they found a seroma and evisceration. It was reported that they explanted and found kinked catheter. When asked to clarify the event, the hcp stated, "no intern, i filled the pump- except port was accessed of return, and there was no return from the reservoir. " regarding the cause of the patient "being stuck so many times," the hcp stated, " i did it - wasn't stuck so many times, stuck to reduce the size of seroma. " it was noted that the patient never had a fever documented, and that they never found infection, but that the patient did have a large seroma. It was reported that the affected devices were explanted because of the kinked cord. They were not able to draw fluid off from access port, and there was none in reservoir. Regarding the current status of the devices, it was stated that the patient was last seen on (b)(6)2012, when the pump and catheter was explanted. The patient's weight at the time of the event was (b)(6). No further complications were reported or anticipated.
 
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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 Key7466502
MDR Text Key106695842
Report Number3004209178-2018-09423
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2009
Device Model Number863740
Device Catalogue Number863740
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 Received04/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/30/2007
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: 04/26/2018 Patient Sequence Number: 1
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