FDA Adverse Event
Death
Summary report: N
KYPHX XPANDER INFLATABLE BONE TAMP 15/3
MDR report key: 1050226
·
Received May 19, 2008
Report
- Report Number
- 2953769-2008-00017
- Event Type
- Death
- Date Received
- May 19, 2008
- Date of Event
- April 21, 2008
- Report Date
- April 21, 2008
- Manufacturer
- MEDTRONIC SPINE LLC
- Product Code
- HXG
- PMA / PMN Number
- K981251
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED, F/U CONVERSATION WITH CO REP.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KYPHX XPANDER INFLATABLE BONE TAMP 15/3 | INFLATABLE BONE TAMP | HXG | MEDTRONIC SPINE LLC | NA | J7121924 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death| R |