FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA MP ICD
MDR report key: 8488716
·
Received April 5, 2019
Report
- Report Number
- 2017865-2019-05067
- Event Type
- Malfunction
- Date Received
- April 5, 2019
- Date of Event
- March 22, 2019
- Report Date
- April 5, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- LWS
- UDI-DI
- 05414734508377
- PMA / PMN Number
- P910023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 THE PATIENT PRESENTED TO THE CLINIC REMOTELY VIA MERLIN.NET WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITING NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING ALERT. FURTHER INVESTIGATION FOUND THAT THE ALERT WAS CAUSED BY OVERSENSING OF T WAVE SIGNAL AFTER VENTRICULAR PACING. PROGRAMMING CHANGES WERE RECOMMENDED BUT NOT PERFORMED. THE HEALTHCARE PROVIDER ELECTED TO KEEP THE CURRENT DEVICE SETTINGS. NO PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281215 | QUADRA ASSURA MP ICD | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CD3369-40Q | A000043815 | 05414734508377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |