FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 2172909
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-10811
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 10, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TS RECOMMENDED REPROGRAMMING. 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 PATIENT IMPLANTED WITH THIS DEVICE HAD RECEIVED CLINICALLY INAPPRIATE THERAPEUTIC SHOCKS. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT REVIEWED THE EPISODE AND STATED THERAPY WAS NOT INHIBITED AS THE RHYTHM HAD BEEN DETECTED IN A MONITOR ONLY ZONE. THE DEVICE WAS THEN IN REDECTION MODE, IN WHICH DETECTION ENHANCEMENTS ARE NOT AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |