FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3213034
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09463
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 2, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 THE REMOTE PATIENT MONITORING SYSTEM RECORDED AN ALERT FOR A HIGH PACE IMPEDANCE MEASUREMENT ON THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. AN ACUTE CHANGE GREATER THAN 500 OHMS WAS OBSERVED. NO FURTHER FOLLOW-UP HAS BEEN PERFORMED AND THE PATIENT'S CLINIC WILL CONTINUE TO MONITOR THEIR SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313497 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | 5072| 7271| 6942| E110 |