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 2013-03-05 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md.
[21105589]
From clinical trial study organizer: it was reported that the device was implanted in pt on (b)(6) 2012 for administration of a clinical trial drug. According to report from clinical trial organizer the pt showed an elevated level of white blood cells in cerebrospinal fluid in (b)(6) 2013. Pt was hospitalized for observation and treated with vancomycin and ceftriaxon. Device was explanted surgically in (b)(6) 2013. No permanent adverse effects to pt reported. At this time there is no other info from other sources to suggest that the presumed infection reported would be caused by the product listed (device was implanted for 7 months before infection-like symptoms were reported).
Patient Sequence No: 1, Text Type: D, B5
[21159782]
Device eval: the device is currently being evaluated; the mfr will file a f/u report detailing the results of the eval once it is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2013-00061 |
| MDR Report Key | 3010909 |
| Report Source | 00,01,06 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-01-30 |
| Date Facility Aware | 2013-01-30 |
| Report Date | 2013-03-01 |
| Date Reported to FDA | 2013-03-01 |
| Date Mfgr Received | 2013-02-01 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2013-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM |
| Generic Name | LNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Product Code | LNY |
| Date Received | 2013-03-05 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 2059573 |
| ID Number | NA |
| Device Expiration Date | 2016-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL MD |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-05 |