FDA Adverse Event
Malfunction
Summary report: N
ACCENT DR RF PACEMAKER
MDR report key: 6178466
·
Received December 15, 2016
Report
- Report Number
- 2938836-2016-18022
- Event Type
- Malfunction
- Date Received
- December 15, 2016
- Date of Event
- November 17, 2016
- Report Date
- November 17, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWP
- PMA / PMN Number
- P030035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED WITH EPISODES OF PVC DUE TO P-OVERSENSING ON THE VENTRICULAR LEAD. LOW R-WAVES AMP WERE ALSO OBSERVED. PROGRAMMING CHANGES WERE MADE. THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830277 | ACCENT DR RF PACEMAKER | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | PM2210 | 4082189 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR |