FDA Adverse Event
Malfunction
Summary report: N
ASSURITY MRI
MDR report key: 8728898
·
Received June 24, 2019
Report
- Report Number
- 2938836-2019-05098
- Event Type
- Malfunction
- Date Received
- June 24, 2019
- Date of Event
- June 10, 2019
- Report Date
- June 24, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- DXY
- UDI-DI
- 05414734509589
- PMA / PMN Number
- P140033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ATRIOVENTRICULAR JUNCTION ABLATION (AVJ) PROCEDURE, DEVICE WAS FOUND TO BE PACED ASYNCHRONOUSLY. IT WAS LATER DETERMINED THAT THE DEVICE SENSE AMPLIFIER WAS LIKELY SATURATED BY THE RF FROM THE ABLATION CATHETER THEREBY CAUSING THE ASYNCHRONOUS PACING. THE PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 521043 | ASSURITY MRI | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | PM2272 | A000044174 | 05414734509589 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |