MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-01-02 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md.
[18625733]
User facility reported that the device was implanted in patient to allow for administration of a clinical trial drug on (b)(6) 2012. On (b)(6) 2012, the patient received an infusion of idursulfase-it via the implanted device. On (b)(6) 2012, the patient developed swelling localized above the injection site. The device was surgically explanted on (b)(6) 2012 due to suspicion of leaking. No permanent adverse effects to patient reported.
Patient Sequence No: 1, Text Type: D, B5
[18762958]
Customer has not yet returned the device to the manufacturer for device evaluation. 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 evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00639 |
| MDR Report Key | 2903598 |
| Report Source | 00,06 |
| Date Received | 2013-01-02 |
| Date of Report | 2012-12-26 |
| Date of Event | 2012-11-16 |
| Date Facility Aware | 2012-11-16 |
| Report Date | 2012-12-26 |
| Date Reported to FDA | 2012-12-26 |
| Date Mfgr Received | 2012-11-26 |
| Date Added to Maude | 2013-01-10 |
| 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 | 2013-01-02 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| 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. Other; 2. Required No Informationntervention | 2013-01-02 |