FDA Adverse Event
Malfunction
Summary report: N
QUARTET
MDR report key: 4935726
·
Received July 23, 2015
Report
- Report Number
- 2017865-2015-27174
- Event Type
- Malfunction
- Date Received
- July 23, 2015
- Date of Event
- June 29, 2015
- Report Date
- June 30, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- OJX
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS AWAKENED BY -THUMPING- ON HER LEFT SIDE AND EXPERIENCED INTERMITTENT -THUMPING- THROUGHOUT THE DAY. DEVICE INTERROGATION REVEALED AN ELEVATED LEFT VENTRICULAR THRESHOLD. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 479777 | QUARTET | PERMANENT PACEMAKER ELECTRODE | OJX | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1458Q/75 | A000003616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |