MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-30 for MEDTRONIC INFUSE BONE GRAFT manufactured by Medtronic.
[5683102]
Caller advised had implant (b)(6) 2012 and experienced dizzy spells 2 weeks after surgery. Suffered falls and head injury from syncope. Other side effects experienced from implant include slurred speech, burning sensation in left hip, tingling in the toes, problems with balancing, poor muscle coordination in hands and chronic pain. Caller advised these negative side effects have affected his ability to work and perform daily activities of living. Caller is bedridden and constantly in pain. They also advised they are part of a class lawsuit against medtronic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041739 |
| MDR Report Key | 4645575 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-30 |
| Date of Event | 2012-05-19 |
| Date Added to Maude | 2015-04-01 |
| 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 | MEDTRONIC INFUSE BONE GRAFT |
| Generic Name | MEDTRONIC INFUSE BONE GRAFT |
| Product Code | NPZ |
| Date Received | 2015-03-30 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-30 |