FDA Adverse Event
Injury
Summary report: N
TRANSVENOUS
MDR report key: 2781053
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-13051
- Event Type
- Injury
- Date Received
- October 10, 2012
- Date of Event
- September 24, 2012
- Report Date
- October 4, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS ULTIMATELY SURGICALLY ABADONED.
Additional Manufacturer Narrative · 1
THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS PRESENT ON THIS RIGHT ATRIAL (RA) LEAD IN BOTH THE UNIPOLAR AND BIPOLAR CONFIGURATIONS. THIS NOISE WAS OVERSENSED AND RESULTED IN MODE SWITCHING AND HIGH RATE PACING. THE LEAD SAFETY SWITCH DID OCCUR. THRESHOLDS WERE 0.8V AT 0.5 MILLISECONDS WITH VARIABLE SENSING. LEAD IMPEDANCES RANGED FROM 580 TO 100 OHMS. THIS PATIENT WAS DEVICE DEPENDENT AND WAS NOT FEELING WELL DUE TO THE LOSS OF AV SYNCHRONY. THE PHYSICIAN WAS CONTEMPLATING INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSVENOUS | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R | 4271| 1273| 1298| S606| 4285 |