FDA Adverse Event
Malfunction
Summary report: N
ABBOTT NGQ DEVICE
MDR report key: 22501358
·
Received July 14, 2025
Report
- Report Number
- 2017865-2025-93040
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 25, 2025
- Report Date
- September 18, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BLUETOOTH TELEMETRY LOSS. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396043 | ABBOTT NGQ DEVICE | NO MATCH | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | NGQ DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |