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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SYNCROMED NON RADIO OPAQUE CATHETER

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MEDTRONIC SYNCROMED NON RADIO OPAQUE CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Staphylococcus Aureus (2058)
Event Date 11/08/2015
Event Type  Injury  
Event Description
I had a syncro med pain pump installed 8 months prior to the date listed. After many months of the surgeons at advanced pain management trying to figure out the pumps problem, i made them explant the device. Since explantation i have had severe pai below the surgical site. When i started questioning the surgeon and his nurses about this i was let go from the clinic. This has still yet to be resolved and i feel abandoned by dr. (b)(6) and dr. (b)(6) at (b)(6) in (b)(6). Medical conditions: dr. (b)(6) infected my spine with (b)(6) during a routine disco gram which led to chronic pain from cervical fusion. C2 thru c7 with instrumentation. Have had multiple lower back surgeries since. Rotator cuff surgery. Lithotripsy on both kidneys. And a non radio opaque catheter has been left in spine after pain pump removal.
 
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Brand NameNON RADIO OPAQUE CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
MEDTRONIC SYNCROMED
MDR Report Key6826695
MDR Text Key83958788
Report NumberMW5071811
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/25/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/29/2017 Patient Sequence Number: 1
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