FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D QUAD RF HV
MDR report key: 7982584
·
Received October 18, 2018
Report
- Report Number
- 2017865-2018-15628
- Event Type
- Malfunction
- Date Received
- October 18, 2018
- Date of Event
- September 19, 2018
- Report Date
- October 22, 2018
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NIK
- UDI-DI
- 05414734508292
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: THE INITIAL REPORTER SHOULD HAVE BEEN DR. (B)(6) JHA FROM THE METHODIST UNIVERSITY HOSPITAL. THE ADDRESS OF THIS FACILITY SHOULD HAVE BEEN 1265 UNION AVE., (B)(4), TN WITH THE INITIAL REPORTER PHONE NUMBER (B)(6).
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 ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE CHECK UP. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED FAR P-WAVE OVERSENSING. THE NEXT DAY THE DEVICE WAS REPROGRAMMED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 822236 | QUADRA ASSURA CRT-D QUAD RF HV | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | CD3365-40Q | 4267221 | 05414734508292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |