MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-03-31 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md.
[15211645]
From clinical trial study organizer: it was reported that the device was implanted in pt for administration of clinical trial drug on (b)(6) 2010. According to report, the pt's system was assessed to allow for administration of scheduled clinical trial drug dose on (b)(6) 2012. Shortly after the injection swelling was noted around the injection site. On (b)(6) 2012, the pt had surgery to revise the system. During surgery it was noted that the outlet tube of the portal had broken. The portal was replaced. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[15751870]
Device has been returned for eval. Once the device has been evaluated the mfr will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00112 |
| MDR Report Key | 2522368 |
| Report Source | 00,06 |
| Date Received | 2012-03-31 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-01-31 |
| Date Facility Aware | 2012-01-31 |
| Report Date | 2012-03-29 |
| Date Reported to FDA | 2012-03-29 |
| Date Mfgr Received | 2012-03-01 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2012-04-10 |
| 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 | 2012-03-31 |
| Returned To Mfg | 2011-03-20 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 1661867 |
| ID Number | NA |
| Device Expiration Date | 2014-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| 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 | 2012-03-31 |