FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 9965929
·
Received April 15, 2020
Report
- Report Number
- 2124215-2020-07513
- Event Type
- Injury
- Date Received
- April 15, 2020
- Date of Event
- March 17, 2020
- Report Date
- April 15, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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
IT WAS REPORTED THAT THIS SYSTEM EXHIBITED NOISE, OVERSENSING AND ELEVATED THRESHOLD MEASUREMENTS ON THE ATRIAL CHANNEL. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE AND ATRIAL LEAD WERE OVED FROM SERVICE AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429052 | NA | PERMANENT DEFIBRILLATOR ELECTRODES | NVY | BOSTON SCIENTIFIC CORPORATION | 4271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| L| R |