FDA Adverse Event
Malfunction
Summary report: N
ALTRUA
MDR report key: 2052792
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04395
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- PMA / PMN Number
- D970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT CAUSED OVERSENSING AND PACING INHIBITION. PATIENT WAS IN COMPLETE HEART BLOCK. THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT CONTACTED PATIENT SERVICES AND STATED THAT THE LEAD HAD DISLODGED. AN EMAIL WAS SENT TO THE BOSTON SCIENTIFIC SALES REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | (B)(4)| 4136| S601| 4456 |