MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-08-18 for SPINAL PAK STIMULATOR UNK * manufactured by Ebi, L.p..
[17805023]
Pt underwent spinal fusion surgery in 03/01. Spinal pak stimulator prescribed on 4/01. Pt subsequently developed cancer and died in 2002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242816-2004-00011 |
| MDR Report Key | 539922 |
| Report Source | 00 |
| Date Received | 2004-08-18 |
| Date of Report | 2004-08-13 |
| Date of Event | 2002-02-20 |
| Date Mfgr Received | 2004-08-11 |
| Date Added to Maude | 2004-08-23 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BARRY SANDS, SR., DIR. |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL PAK STIMULATOR |
| Generic Name | EXTERNAL STIMULATOR |
| Product Code | GZI |
| Date Received | 2004-08-18 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 529230 |
| Manufacturer | EBI, L.P. |
| Manufacturer Address | * GUAYNABO PR * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-08-18 |