FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3052638
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04214
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- February 26, 2013
- Report Date
- February 27, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SINGLE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE CHRONIC VALUES HAVE BEEN CONSISTENT AND NO EPISODES OF NOISE FOUND. THE FIELD REPRESENTATIVE WILL DISCUSS THE ISSUE WITH THE HEALTH CARE PROFESSIONAL (HCP) AND WILL PLAN FURTHER TROUBLESHOOTING AT NEXT MONTHS SCHEDULED OFFICE VISIT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154512 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | E110| 0181| MISMATCH |