FDA Adverse Event
Injury
Summary report: N
CURRENT ACCEL DR
MDR report key: 3911052
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-12946
- Event Type
- Injury
- Date Received
- July 2, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT T-WAVE OVERSENSING WAS OBSERVED. PATIENT IS PACEMAKER DEPENDENT. DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386174 | CURRENT ACCEL DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |