FDA Adverse Event
Injury
Summary report: N
CURRENT DR RF
MDR report key: 3801268
·
Received May 8, 2014
Report
- Report Number
- 2938836-2014-10914
- Event Type
- Injury
- Date Received
- May 8, 2014
- Date of Event
- January 29, 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 Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF NOISE WAS CONFIRMED VIA STORED ELECTROGRAMS. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE FIELD EVENT COULD NOT BE DETERMINED AS THE NOISE COULD NOT BE REPRODUCED IN THE LABORATORY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS WHILE WALKING ON THE TREADMILL. UPON INTERROGATION, MULTIPLE VF EPISODES WERE NOTED. THE INITIAL EPISODE WAS DUE TO SVT WITH FREQUENT PVCS; THEREAFTER, THE INAPPROPRIATE SHOCKS WERE DUE TO LEAD NOISE. NOISE WAS NOT REPRODUCIBLE IN CLINIC. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278767 | CURRENT DR RF | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | 2207-30 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | 1581/65, RH30195 |