FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2911970
·
Received January 11, 2013
Report
- Report Number
- 2124215-2012-16395
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Date of Event
- December 2, 2012
- Report Date
- February 1, 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
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 INDICATES THAT THE PATIENT WILL CONTINUED TO BE FOLLOWED AT THIS TIME. NO SURGICAL INTERVENTION HAS BEEN PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17084 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | 0137| E102 |