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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. A JOHNSON & JOHNSON COMPANY CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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CODMAN & SHURTLEFF, INC. A JOHNSON & JOHNSON COMPANY CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Device Problems Excess Flow or Over-Infusion (1311); Nonstandard Device (1420)
Patient Problems Pain (1994); Paresis (1998); Impaired Healing (2378); Confusion/ Disorientation (2553)
Event Date 11/01/2017
Event Type  Injury  
Event Description
On (b)(6) 2017: patient started having issues with the infusion pump and catheter.Pt felt a large amount of medication been delivered by the infusion pump.A week later, pt started having delusional thought.Pt was having severe back pain and he went to his doctor and he was told the pump needed to be taken out due to pump failure.The pump caused swelling to his leg and pt lost sensation to his feet.Pt stated he was some how retaining medication.The pump was taken out on (b)(6) 2018 and pt is feeling better.The swelling in his leg is gone but there is a possibility that he might lose his big toe due to non-healing wound.Pt is still suffering from ed, low testosterone and he has lost 108 lbs.The pump has been recalled.
 
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Brand Name
CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
Type of Device
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. A JOHNSON & JOHNSON COMPANY
MDR Report Key7772930
MDR Text Key116855885
Report NumberMW5079052
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/28/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
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