FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3251619
·
Received July 29, 2013
Report
- Report Number
- 2124215-2013-12103
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 22, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FROM THIS SYSTEM DUE TO A LOW SHOCKING IMPEDANCE MEASUREMENT. THE MEASUREMENT TODAY WAS 3 OHMS AND A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT BELIEVES THIS IS DUE TO THE LOW AMPLITUDE PULSE THAT IS SENT FOR THE DAILY MEASUREMENT. THE SHOCK IMPEDANCE HAS BEEN VERY STABLE IN THE 50 OHM RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353639 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | A155| 0158| 4470| E110 |