MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-25 for EBI BONE STIMULATOR manufactured by Medical Inc.
[2728925]
Pt had a spinal fusion on (b)(6) 2007. A bone stimulator was implanted with lead into the spine. In (b)(6) 2007, neurological surgeon sent him to do mri. During the mri the lead from the implanted bone stimulator became very hot and unbearable and pt had to stop procedure. After this happened, the stimulator stopped working and had to be removed on (b)(6) 2008. The lead still remained in the spine. This incident caused neurological damages, pain and suffering to the pt. He reports that he was never educated or informed on the effects of mri on the stimulator and even after numerous contacts with his dr no warning on the mri has been given to him. He found out about the effects by himself researching online.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025932 |
| MDR Report Key | 2628891 |
| Date Received | 2012-06-25 |
| Date of Report | 2012-06-25 |
| Date of Event | 2007-11-01 |
| Date Added to Maude | 2012-06-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EBI BONE STIMULATOR |
| Generic Name | BONE STIMULATOR |
| Product Code | LOE |
| Date Received | 2012-06-25 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INC |
| Manufacturer Address | 100 INTERPLACE PKWY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-25 |