FDA Adverse Event
Injury
Summary report: N
CURRENT ACCEL VR
MDR report key: 1955302
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00460
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 11, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE REPORTED ANOMALIES OBSERVED IN THE FIELD WERE NOT CONFIRMED. THE DEVICE'S FUNCTIONALITY WAS TESTED ON THE BENCH AND WAS FOUND TO BE NORMAL. ALL IMPEDANCE MEASUREMENTS WERE NORMAL. THE DEVICE'S HEADER WIRES WERE X-RAY INSPECTED. NO ANOMALY WAS DETECTED. THE CAUSE OF THE FIELD ANOMALY WAS NOT CONCLUSIVELY DETERMINED, BUT SUSPECTED IT WAS DUE TO A DEVICE/LEAD CONNECTION ISSUE.
Description of Event or Problem · 1
THE PATIENT RECEIVED A NOTIFICATION FOR HIGH IMPEDANCE. HIGH THRESHOLDS WERE ALSO MEASURED. POSSIBLE LEAD FRACTURE OR LOOSE CONNECTION WAS SUSPECTED. WHEN THE PHYSICIAN OPENED THE POCKET, THE PROXIMAL PARTS OF THE LEAD WERE FOUND BENT AT AN ACUTE ANGLE. THE DEVICE AND LEAD WERE EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT ACCEL VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention | 7122/60 (B)(4) |