MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-09-24 for KYPHX EXPRESS INFLATABLE BONE TAMP, 15/2 K15B manufactured by Medtronic Spine Llc.
[1373544]
It was reported that a pt underwent a kyphoplasty procedure at levels t12-l1. The bilateral balloon inflation at t12 occurred without incident. As the physician introduced and inflated the balloons to l1 bilaterally, the pt was gradually desaturating until she became bradycardic and then hypotensive. The physician was able to regain blood-oxygen saturation to 100% via bag-mask ventilation, however, the pt's cardiac function continued to deteriorate and she went into pulseless electrical activity, despite the presence of a pacemaker. The cannulas were removed at this point, and the pt was placed on her back and aggressive resuscitation methods were employed. The pt expired. It was noted that bone cement was not delivered. Monitored anesthesia care was used for this procedure because, of the pt's significantly compromised cardiac function. No additional info was reported.
Patient Sequence No: 1, Text Type: D, B5
[8706883]
Device not returned; followed up with company rep.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2010-00531 |
| MDR Report Key | 1847899 |
| Report Source | 05,07 |
| Date Received | 2010-09-24 |
| Date of Report | 2006-07-07 |
| Date of Event | 2006-07-07 |
| Date Mfgr Received | 2006-07-07 |
| Date Added to Maude | 2010-10-01 |
| 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 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 EXPRESS INFLATABLE BONE TAMP, 15/2 |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2010-09-24 |
| Model Number | NA |
| Catalog Number | K15B |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SPINE LLC |
| Manufacturer Address | 1221 CROSSMAN AVE. SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2010-09-24 |