PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2012-10-16 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md, Inc..

Event Text Entries

[16129013] From clinical trial study organizer: it was reported that the device was implanted in pt on (b)(6) 2010 for administration of a clinical trial drug. According to treating physician, pt showed an elevated level of white blood cells in cerebrospinal fluid in (b)(6) 2012. In (b)(6) 2012, the pt was hospitalized for vancomycin treatment due to suspicion of bacterial infection; the pt? S white blood cell count returned to normal range after this treatment. According to treating physician, on (b)(6) 2012 the pt? S white blood cell count was found elevated. Pt was hospitalized for observation and treated with paracetamol for subfebrile temperature. Device was explanted surgically on (b)(6) 2012. No permanent adverse effects to pt reported.
Patient Sequence No: 1, Text Type: D, B5


[16245980] Customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a follow-up report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2012-00484
MDR Report Key2803009
Report Source00,01,06
Date Received2012-10-16
Date of Report2012-10-12
Date of Event2012-09-17
Date Facility Aware2012-09-17
Report Date2012-10-12
Date Reported to FDA2012-10-12
Date Mfgr Received2012-09-14
Device Manufacturer Date2010-04-01
Date Added to Maude2012-10-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPETE HIRTE
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287384
Manufacturer G1SMITHS MEDICAL MD, INC.
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM
Generic NameLNY-CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Product CodeLNY
Date Received2012-10-16
Model Number21-1500
Catalog Number21-1500
Lot Number1768497
ID NumberNA
Device Expiration Date2015-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age3 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL MD, INC.
Manufacturer AddressST. PAUL MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-10-16

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