FDA Adverse Event
Malfunction
Summary report: N
ATLAS II PLUS DR
MDR report key: 3901017
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12624
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- May 12, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DEVICE CHECK ON A ROUTINE FOLLOW UP, HIGH HV LEAD IMPEDANCE WAS OBSERVED. A SECOND IMPEDANCE MEASUREMENT TESTING WAS DONE AND IMPEDANCE DECELERATED ON A LOWER VALUE. TELEMETRY ANOMALY WAS SUSPECTED. PATIENT IS SCHEDULED FOR FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380906 | ATLAS II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-268 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7122/65, (B)(4) |