FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3212520
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09290
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 20, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- PHYSICIAN
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 THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PACING INHIBITION DUE TO OVERSENSING OF ATRIAL ACTIVITY BY THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT IS PACER DEPENDENT EXPERIENCED ASYSTOLE GREATER THAN TWO SECONDS. THE SENSITIVITY WAS INCREASED AND THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313114 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | 4087| A135| E110| 0157 |