MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-05-19 for KYPHX XPANDER INFLATABLE BONE TAMP 15/3 K09A manufactured by Medtronic Spine Llc.
[867145]
During a single level balloon kyphoplasty procedure at level l2, a pt went into cardiac arrest. It was reported that after two balloons were fully inflated, the pt's co2 levels began to drop. The treating physician completed the procedure within a few mins, and after the pt was turned over from prone position, the anesthesiologist performed cpr for about 40 mins, but was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[8086253]
Device not returned, f/u conversation with co rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2008-00017 |
| MDR Report Key | 1050226 |
| Report Source | 05,07 |
| Date Received | 2008-05-19 |
| Date of Report | 2008-04-21 |
| Date of Event | 2008-04-21 |
| Date Mfgr Received | 2008-04-21 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2008-05-29 |
| 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 | LAURENCE WALLMAN, DIR |
| Manufacturer Street | 1221 CROSSMAN AVE. |
| 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 15/3 |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2008-05-19 |
| Model Number | NA |
| Catalog Number | K09A |
| Lot Number | J7121924 |
| ID Number | NA |
| Device Expiration Date | 2010-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1020275 |
| Manufacturer | MEDTRONIC SPINE LLC |
| Manufacturer Address | 1221 CROSSMAN AVE. SUNNYVALE CA 94089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2008-05-19 |