FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
MDR report key: 1851580
·
Received October 4, 2010
Report
- Report Number
- 2124215-2010-13927
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- July 8, 2010
- Report Date
- June 15, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
ANALYSIS OF THE ELECTROCARDIOGRAMS BY TECHNICAL SERVICES NOTED NO NOISE ON THE SHOCK CHANNEL. TECHNICAL SERVICES DISCUSSED A POSSIBLE LEAD ISSUE OR A CONNECTION ISSUE. A FOLLOW UP WAS RECOMMENDED FOR THIS PATIENT IN ORDER TO EVALUATE THE ROOT CAUSE OF THE HIGH SHOCKING IMPEDANCES. NO CHANGE AT THIS TIME. UPON FURTHER INFORMATION THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS TRIGGERED DUE TO HIGH OUT OF RANGE SHOCKING IMPEDANCES INVOLVING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AT THIS TIME NO ACTION HAS BEEN TAKEN TO ADDRESS THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |