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 2012-06-22 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md.
[2731222]
User facility reported that the device was implanted in pt to allow for administration of a clinical trial drug on (b)(6) 2011. On (b)(6) 2011 an x-ray examination was performed which showed that the catheter had migrated from the pt's spinal space. The device was explanted on (b)(6) 2012 with a new device implanted the same day. No permanent adverse effects to pt reported.
Patient Sequence No: 1, Text Type: D, B5
[10118800]
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 | 2183502-2012-00247 |
| MDR Report Key | 2632472 |
| Report Source | 00,01,06 |
| Date Received | 2012-06-22 |
| Date of Report | 2012-06-15 |
| Date of Event | 2011-10-10 |
| Date Facility Aware | 2011-10-10 |
| Report Date | 2012-06-15 |
| Date Reported to FDA | 2012-06-15 |
| Date Mfgr Received | 2012-05-16 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-06-29 |
| 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 | 2012-06-22 |
| Returned To Mfg | 2012-06-07 |
| 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 | R |
| Device Age | 2 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 | 2012-06-22 |