FDA Adverse Event
Injury
Summary report: N
AMPERE GENERATOR EGM 4 LEAD CABLE
MDR report key: 10432681
·
Received August 20, 2020
Report
- Report Number
- 2184149-2020-00124
- Event Type
- Injury
- Date Received
- August 20, 2020
- Date of Event
- August 12, 2020
- Report Date
- August 20, 2020
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- OAD
- PMA / PMN Number
- P110016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF INSPECTION RESULTS FOR THIS LOT NUMBER CONFIRMED THAT NO NON-CONFORMANCES WERE IDENTIFIED RELATED TO THE REPORTED EVENT AND THE PRODUCT MET ABBOTT SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED
Description of Event or Problem · 1
THE CONNECTOR FOR THE EGM OUT CABLE FELL OFF DURING THE PROCEDURE AND THE CASE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 897577 | AMPERE GENERATOR EGM 4 LEAD CABLE | EP GENERATOR | OAD | ST. JUDE MEDICAL, INC. | 100081279 | 7305623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |