FDA Adverse Event
Injury
Summary report: N
CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
MDR report key: 6119591
·
Received November 21, 2016
Report
- Report Number
- 2938836-2016-14620
- Event Type
- Injury
- Date Received
- November 21, 2016
- Date of Event
- October 11, 2016
- Report Date
- October 11, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO POST-PACED T-WAVE OVERSENSING. THE DEVICE DETECTED T-WAVES FOLLOWED BY R-WAVE VARIATION. PROGRAMMING CHANGES AND DFT TESTING WERE RECOMMENDED. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767123 | CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2211-36Q | 3081105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |