FDA Adverse Event
Injury
Summary report: N
CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
MDR report key: 4864007
·
Received June 23, 2015
Report
- Report Number
- 2938836-2015-26328
- Event Type
- Injury
- Date Received
- June 23, 2015
- Date of Event
- April 27, 2015
- Report Date
- April 29, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- 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 A STORED ALERT FOR LOW, OUT OF RANGE HV LEAD IMPEDANCE DURING THERAPY WAS OBSERVED. SUBSEQUENTLY, AN ALERT FOR LOW, OUT OF RANGE PACING LEAD IMPEDANCE AND AN INCREASE IN THRESHOLD WERE OBSERVED ON THE ATRIAL LEAD. AS A RESULT, THE SYSTEM WAS EXPLANTED AND REPLACED WITHOUT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405385 | CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2211-36Q | 2860679 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | 7120Q/52, BJN10458| 1688TC/46, DM102943 |