FDA Adverse Event
Malfunction
Summary report: N
ABBOTT NGQ DEVICE
MDR report key: 15428576
·
Received September 15, 2022
Report
- Report Number
- 2017865-2022-38240
- Event Type
- Malfunction
- Date Received
- September 15, 2022
- Date of Event
- August 31, 2022
- Report Date
- October 7, 2022
- Manufacturer
- ABBOTT
- Product Code
- NIK
- UDI-DI
- 05415067032010
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING A REMOTE FOLLOW-UP, THERE WAS AN ISSUE RETRIEVING THE DIAGNOSTIC TEMPLATE FROM THE DEVICE RECORDS. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1531249 | ABBOTT NGQ DEVICE | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ABBOTT | CDHFA500Q | P000141471 | 05415067032010 |
| 427074 | ABBOTT NGQ DEVICE | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ABBOTT | CDHFA500Q | P000141471 | 05415067032010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |