MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-09 for ORTHO * manufactured by Ortho.
[19547230]
An orthopedist prescribed orth extracorporeal shock wave therapy to treat my injured shoulder as an alternative to surgery. After the second treatment, i was left with injury to my spine, nerve damage on both sides of the neck, narrowed disks and arteries with disk protrusion -up to 4. 2 mm, severe pain in head, neck, and spine, constant crunching noises in head and neck. I've lost 26 pounds since february -without trying-. Doctors who have seen me since, including recommending dr recommends removal of at least two disks in my neck to get some relief. This would be replaced by a bone from the hip. I've discovered, too late, that there are many scientific papers out there on the possible side effects of eswt to the spine, and that the mechanics of eswt are not yet full. Arteries are narrowing, and it is possible that oxygen can get to the brain as it should. There has been medical malpractice in my case and i am now wondering if extracorporeal shock wave therapy to the shoulder has been approved by the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036430 |
| MDR Report Key | 751636 |
| Date Received | 2003-07-09 |
| Date of Report | 2003-07-09 |
| Date Added to Maude | 2006-08-18 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO |
| Generic Name | EXTRACORPOREAL SHOCK WAVE THERAPY |
| Product Code | NBN |
| Date Received | 2003-07-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 739453 |
| Manufacturer | ORTHO |
| Manufacturer Address | 3303 HARBOR BLVD SUITE #H2 COSTA MESA CA 92626 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Deathisabilit | 2003-07-09 |