FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3760860
·
Received April 21, 2014
Report
- Report Number
- 2124215-2014-08842
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Date of Event
- April 18, 2012
- Report Date
- February 20, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- PMA / PMN Number
- P960040
- 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 THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED NO INTERVENTION PLANNED TO TAKE PLACE AT THIS TIME. PER THE CLINIC NURSE THE PACING THRESHOLDS AND SENSING HAVE REMAINED UNCHANGED. THE PACING IMPEDANCE MEASUREMENTS HAVE HISTORICALLY BEEN HIGHER THAN AVERAGE. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239693 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | 4470| A135| 0147| E110 |