FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 1992114
·
Received February 15, 2011
Report
- Report Number
- 2182208-2011-00174
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- K790766
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD INCREASING THRESHOLDS AND NOISE WAS FOUND ON THE ELECTROGRAM. IT WAS ALSO REPORTED THAT THERE WERE HIGH RATE EPISODES NOTED. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | 6907R | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Other |