MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2010-09-24 for KYPHX XPANDER INFLATABLE BONE TAMP UNK manufactured by Medtronic Spine Llc.
[18958263]
Method; device was returned, follow up conversation with company representative.
Patient Sequence No: 1, Text Type: N, H10
[18980995]
It was reported that a patient was admitted to the hospital for kyphoplasty procedure and was under local/conscious sedation. After the first balloon was inflated, the patient experienced a 15-30 second seizure followed by another seizure. The procedure was stopped. The patient was intubated and transferred to the icu with a mild fever. She was extubated again 24 hours later and returned to baseline. No bone cement was ever delivered into the patient. Under local/conscious sedation. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953769-2010-00480 |
| MDR Report Key | 1846269 |
| Report Source | 01,05,07 |
| Date Received | 2010-09-24 |
| Date of Report | 2006-05-03 |
| Date of Event | 2006-04-26 |
| Date Mfgr Received | 2006-05-03 |
| Date Added to Maude | 2010-09-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL ARMSTRONG, SR. DIRECTOR |
| Manufacturer Street | 1221 CROSSMAN AVENUE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085486500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX XPANDER INFLATABLE BONE TAMP |
| Generic Name | KYPHOPLASTY |
| Product Code | HXG |
| Date Received | 2010-09-24 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SPINE LLC |
| Manufacturer Address | 1221 CROSSMAN AVENUE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-24 |