FDA Adverse Event
Injury
Summary report: N
TEMPUS LS-MANUAL
MDR report key: 17590028
·
Received August 21, 2023
Report
- Report Number
- 3003832357-2023-00552
- Event Type
- Injury
- Date Received
- August 21, 2023
- Date of Event
- August 3, 2023
- Manufacturer
- SCHILLER AG
- Product Code
- LDD
- UDI-DI
- 07613365002737
- PMA / PMN Number
- K200849
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
PREVIOUSLY REPORTED ON (B)(4) WITH MDR# 3003832357-2023-00535. DEVICE INVESTIGATION IS HOUSED WITHIN (B)(4).
Description of Event or Problem · 0
IT HAS BEEN REPORTED THAT THE DEVICE IS EXPERIENCING ISSUES WITH PACING DURING A PATIENT USE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1090804 | TEMPUS LS-MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Life Threatening |