FDA Adverse Event
Malfunction
Summary report: N
LUMAX 340 DR-T
MDR report key: 1012752
·
Received March 12, 2008
Report
- Report Number
- 1028232-2008-00215
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- January 15, 2008
- Report Date
- February 11, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS RETURNED WITH OOS DOCUMENTATION FROM A BIOTRONIK REPRESENTATIVE. THIS LEAD WAS SENSING INAPPROPRIATELY AND THE SYSTEM WAS GIVING INAPPROPRIATE SHOCKS. THE VENTRICLE LEAD WAS REPOSITIONED ONCE, AND WHEN THE INAPPROPRIATE SENSING AND SHOCKS CONTINUED, THE WHOLE SYSTEM WAS REMOVED. IT WAS REPLACED WITH LUMAX 340 DR-T. AFTER THE SYSTEM WAS EXCHANGED, THE DOCTOR AND REPRESENTATIVE WERE TOLD THAT THE PATIENT HAD BEEN SLEEPING ON AN ELECTRIC BED. ALSO REMOVED: LINOX SD 65/16, 1028232-2008-00214. SETROX S 45, 1028232-2008-00213.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 DR-T | ICD | MRM | BIOTRONIK GMBH AND CO. | 355267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |