FDA Adverse Event
Malfunction
Summary report: N
2124215-2013-09993
MDR report key: 3211579
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-09993
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 3, 2013
- Report Date
- May 6, 2013
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS DURING A SCHEDULED DEVICE CHECK. THERE WERE NO OTHER ISSUE AND THE PHYSICIAN FEELS THERE IS MOST LIKELY NO ISSUE WITH THIS LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309371 | NVY | GUIDANT PUERTO RICO BV | TACHY LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | MISMATCH| K187 |