FDA Adverse Event
Malfunction
Summary report: N
LUMAX 340 DR-T
MDR report key: 2942098
·
Received December 27, 2012
Report
- Report Number
- 1028232-2012-03440
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Date of Event
- September 27, 2012
- Report Date
- December 10, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. OUTPUTS HAVE BEEN LOW (2.0 V @ 0.5 MS) FOR BOTH LEADS FROM 3 MONTH VISITS ((B)(6) 2009) TO DEVICE CHANGE-OUT. THEY WERE INITIALLY HIGHER AT ENROLLMENT (4.8V @ 0.5MS). AT THE VISIT PRIOR TO REPLACEMENT, THERE WERE A FEW SHOCKS. AT IMPLANT, THEY HAD 4 DELIVERED SHOCKS AND TWO TERMINATED SHOCKS. SINCE IMPLANT, THERE HAVE BEEN 5 MORE TERMINATED SHOCKS AND 1 DELIVERED SHOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 DR-T | MRM | BIOTRONIK SE & CO. KG | 355267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization |