FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 1944732
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-20717
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 8, 2010
- Report Date
- October 8, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- 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 HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. A LOOSE SETSCREW WAS DISCOVERED AND A REVISION PROCEDURE WAS PERFORMED WERE THE SETSCREW WAS TIGHTENED AND DURING THE PROCEDURE, SLACK WAS ADDED TO THE RV AND RIGHT ATRIAL (RA) LEAD'S. NORMAL RV IMPEDANCE MEASUREMENTS WERE OBSERVED POST REVISION PROCEDURE. NO ADDITIONAL 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 | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Life Threatening| R | 4135| S603| 4136 |