FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2913298
·
Received January 14, 2013
Report
- Report Number
- 2124215-2013-00294
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 10, 2012
- Report Date
- May 23, 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
ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.
Additional Manufacturer Narrative · 1
EFFORTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE CLINICAL OBSERVATIONS WERE UNSUCCESSFUL. THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS RECEIVED FOR THIS SYSTEM DUE TO LOW SHOCKING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20982 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | E102| 0125| 1860| 1741 |