FDA Adverse Event
Malfunction
Summary report: N
NO MATCH
MDR report key: 23145529
·
Received September 25, 2025
Report
- Report Number
- 2017865-2025-1001143
- Event Type
- Malfunction
- Date Received
- September 25, 2025
- Report Date
- October 16, 2025
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTION: PLEASE RETRACT THIS REPORT 2017865-2025-1001143, REVIEW OF ADDITIONAL INFORMATION INDICATES THAT THE REPORT IS A DUPLICATE AND WAS HANDLED IN 2017865-2025-99650.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT'S DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1613758 | NO MATCH | LWS | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |