FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2913768
·
Received January 14, 2013
Report
- Report Number
- 2124215-2013-00024
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 22, 2012
- Report Date
- February 14, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- PHYSICIAN
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
ADDITIONAL INFORMATION HAS BEEN PROVIDED THAT THIS IS A DEVICE SPECIFIC ISSUE, NOT A LEAD ISSUE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATES THAT THE PHYSICIAN HAS OPTED TO WATCH DAILY IMPEDANCES TO SEE IF THERE WILL BE A RECURRENCE, IF SO, FURTHER TESTING WILL BE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20508 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | 0175| E102 |