FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2914306
·
Received January 14, 2013
Report
- Report Number
- 2124215-2013-00896
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- November 15, 2012
- Report Date
- November 26, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD AND ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED SHOCK IMPEDANCE MEASUREMENTS THAT WERE OUT OF RANGE. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT THE PATIENT WILL CONTINUE TO BE FOLLOWED VIA LATITUDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AVAILABLE INFORMATION INDICATES THAT THE SYSTEM REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21075 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | E110| 0138| 4469 |