FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 3043369
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-02519
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- January 23, 2013
- Report Date
- January 23, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK LEAD IMPEDANCES. THE PATIENT'S PHYSICIAN IS AWARE OF THE SITUATION AN THE PACING SYSTEM REMAINS IMPLANTED AT THIS TIME. (THE RIGHT VENTRICULAR (RV) LEAD MODEL AND SERIAL NUMBER IS UNKNOWN) THE PATIENT WILL BE MONITORED CLOSELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145821 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |