FDA Adverse Event
Injury
Summary report: N
TELIGEN
MDR report key: 1952535
·
Received January 7, 2011
Report
- Report Number
- 2124215-2010-23388
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 3, 2010
- Report Date
- December 3, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P010012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCES. A SURGICAL PROCEDURE WAS PERFORMED WHERE IT WAS DETERMINED THAT THE DISTAL HIGH VOLTAGE SET SCREW WAS LOOSE. THE SET SCREW WAS RE-TIGHTENED WITHOUT FURTHER ISSUE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | T175| E102| 0158 |