MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-08-21 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md.
[2990022]
From clinical trial study organizer: it was reported that the device was implanted in pt for administration of clinical trial drug on (b)(6) 2012. According to report, on (b)(6) the device was non-functional during infusion attempts through the system. The system was surgically explanted on (b)(6) 2012 and a new system was implanted. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[10032598]
Reporter has not yet returned the device to the manufacturer for device eval. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00394 |
| MDR Report Key | 2715503 |
| Report Source | 00,06 |
| Date Received | 2012-08-21 |
| Date of Report | 2012-08-19 |
| Date of Event | 2012-07-24 |
| Date Facility Aware | 2012-07-24 |
| Report Date | 2012-08-19 |
| Date Reported to FDA | 2012-08-19 |
| Date Mfgr Received | 2012-07-30 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-08-28 |
| 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 | 2012-08-21 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 1661867 |
| ID Number | NA |
| Device Expiration Date | 2015-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-08-21 |