MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2015-05-12 for NIM-ECLIPSE? PROBE 945SPK1004 manufactured by Medtronic Sofamor Danek Usa, Inc.
[5787576]
This event has previously been reported by medtronic spinal (mfr report # 1030489-2013-03807). However, it was determined that the procedure involved the nim eclipse probe, a medtronic xomed product. Therefore, an additional mdr is being submitted to include the medtronic xomed product. It was reported that on (b)(6) 2010, patient underwent a lateral lumbar spinal fusion procedure at l4-5 with a medtronic peek cage. To achieve fusion, surgery was performed using rhbmp-2/acs. Post operatively, patient suffered significant pain in the area of the fusion surgery and extremities. As a result of fusion surgery with rhbmp-2/acs, patient received significant medical treatment to care for rhbmp-2/acs related injuries. The patient never recovered from the surgery involving the use of rhbmp-2/acs, and continues to suffer from daily, disabling pain that prevents patient from performing many basic activities of daily living.
Patient Sequence No: 1, Text Type: D, B5
[13357343]
(b)(4). The device was not returned. Therefore, a product analysis has not been performed. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
[100166125]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-00954 |
| MDR Report Key | 4766507 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-05-12 |
| Date of Report | 2013-08-08 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2015-04-17 |
| Date Added to Maude | 2015-05-12 |
| 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 | URIZA SHUMS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328405 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NIM-ECLIPSE? PROBE |
| Generic Name | ELECTRODE, NEEDLE |
| Product Code | GXZ |
| Date Received | 2015-05-12 |
| Model Number | 945SPK1004 |
| Catalog Number | 945SPK1004 |
| Lot Number | 090926001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-12 |