FDA Adverse Event
Injury
Summary report: N
EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
MDR report key: 8204165
·
Received December 28, 2018
Report
- Report Number
- 2184149-2018-00205
- Event Type
- Injury
- Date Received
- December 28, 2018
- Date of Event
- November 30, 2018
- Report Date
- February 19, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- DQK
- UDI-DI
- 05415067003126
- PMA / PMN Number
- K151911
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED.
Description of Event or Problem · 1
DURING AN ABLATION PROCEDURE, THE INTRACARDIAC SIGNALS WERE INTERMITTENTLY LOST. THE LEADS WERE CHECKED AND SECURE ON THE PATIENT. THE PROCEDURE WAS CANCELLED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1041288 | EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL | PROGRAMMABLE DIAGNOSTIC COMPUTER | DQK | ST. JUDE MEDICAL, INC. | 09-1462-0056 | 05415067003126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |