FDA Adverse Event
Malfunction
Summary report: N
ACCENT DR RF PACEMAKER
MDR report key: 7001795
·
Received November 3, 2017
Report
- Report Number
- 2938836-2017-33598
- Event Type
- Malfunction
- Date Received
- November 3, 2017
- Date of Event
- October 23, 2017
- Report Date
- November 3, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWP
- PMA / PMN Number
- P030035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP. A CYBER SECURITY UPDATE WAS ATTEMPTED AND THE DEVICE ENTERED BVVI. AN FSM STATE ACTION ERROR MESSAGED DISPLAYED UPON INTERROGATION. THE DEVICE WAS RESTORED AND THE FIRMWARE WAS UPGRADED. THE PATIENT WAS ASYMPTOMATIC. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778496 | ACCENT DR RF PACEMAKER | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | PM2210 | 3325965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |