FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2840301
·
Received November 20, 2012
Report
- Report Number
- 2182208-2012-04040
- Event Type
- Injury
- Date Received
- November 20, 2012
- Report Date
- November 8, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE, NOISE AND WAS CAUSING POCKET STIMULATION. THE LEAD WAS PROGRAMMED OFF AND LET IN PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTRODE, PACEMAKER, PERMANENT | DTB | RICE CREEK MFG | 4965-35 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 4965 IMPLANTABLE PACING LEAD |