FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 3152471
·
Received June 7, 2013
Report
- Report Number
- 6000030-2013-00136
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 3, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS WITH INTERMITTENT CAPTURE, NO CAPTURE AT MAXIMUM OUTPUTS AND HIGH IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252827 | ELECTRODE, PACEMAKER, PERMANENT | DTB | RICE CREEK MFG | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR | Hospitalization| R | P1501DR IMPLANTABLE PULSE GENERATOR |