FDA Adverse Event
Malfunction
Summary report: N
META DDDR
MDR report key: 152225
·
Received February 6, 1998
Report
- Report Number
- 2017865-1997-01362
- Event Type
- Malfunction
- Date Received
- February 6, 1998
- Date of Event
- September 1, 1997
- Report Date
- September 3, 1997
- Manufacturer
- TELECTRONICS PACING SYSTEMS INC
- Product Code
- DXY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED FROM THE FIELD NOTES THAT DURING TRANS- TELEPHONIC MONITORING, A LOSS OF CAPTURE WAS OBSERVED. THE SALE S REPRESENTATIVE SAW THE PATIENT TO CHECK THE DEVICE AND FOUND NO CAPTURE IN BIPOLAR OR UNIPOLAR ONN BOTH CHANNELS. THE PATIENT HAD AN INTRINSIC RHYTHM OF ABOUT 70 BPM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | META DDDR Implant | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | TELECTRONICS PACING SYSTEMS INC | 1250H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |