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..
[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
| Report Number | 2183502-2012-00484 |
| MDR Report Key | 2803009 |
| Report Source | 00,01,06 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-09-17 |
| Date Facility Aware | 2012-09-17 |
| Report Date | 2012-10-12 |
| Date Reported to FDA | 2012-10-12 |
| Date Mfgr Received | 2012-09-14 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-10-25 |
| 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 |
| Manufacturer G1 | SMITHS MEDICAL MD, INC. |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| 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 | 2012-10-16 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 1768497 |
| ID Number | NA |
| Device Expiration Date | 2015-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL MD, INC. |
| Manufacturer Address | ST. PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-16 |