FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 2173351
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-11014
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 12, 2011
- Report Date
- June 12, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS RV LEAD WAS SUBSEQUENTLY REVISED AND THERE WAS NO FURTHER ISSUE FOLLOWING. IF NEW INFORMATION WERE TO BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT GREATER THAN 2,000 OHMS PACE IMPEDANCE TWO DAYS POST-IMPLANT. THRESHOLDS WERE NOT IDEAL AND ALSO DIAPHRAGMATIC STIMULATION WAS OCCURRING. A CAT SCAN SHOWED THAT THIS LEAD HAD PERFORATED INTO THE PERICARDIUM ABOUT TWO CENTIMETERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | E110| 4136| MISMATCH |