FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE ST VR, DF-4 CONNECTOR
MDR report key: 3910978
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-13005
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- May 29, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PREVIOUSLY REPORTED PATIENT CODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION WERE THE INDICATION FOR ICD IMPLANT, NOT AN ADVERSE EVENT AS A RESULT OF A DEVICE MALFUNCTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED AN ERRONEOUS ALERT THAT THE CHARGE TIME LIMIT HAD BEEN REACHED OVER A YEAR PRIOR TO IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT RECEIVED A NOTIFICATION ALERT FOR MULTIPLE VT/VF EPISODES. FURTHER REVIEW OF SESSION RECORDS NOTED DELIVERY OF SHOCKS FOR VF AND HV CHARGES. AS A RESULT, THE CAPACITOR CHARGE TIME LIMIT REACHED AND DEVICE BATTERY IS LESS THAN TWO YEARS OF LONGEVITY REMAINING. THE DEVICE REMAINS IMPLANTED; PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386650 | ELLIPSE ST VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1277-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |