FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3211585
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08743
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 4, 2013
- Report Date
- May 5, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P010012
- 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 THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE PACING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THIS RV LEAD ALSO EXHIBITED SOME NOISE WHICH LEAD TO NON SUSTAINED EVENTS. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309373 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | 0185| E102 |