FDA Adverse Event
Other
Summary report: N
PRX IMPLANTABLE DEFIBRILLATOR
MDR report key: 25314
·
Received September 8, 1995
Report
- Report Number
- MW1006883
- Event Type
- Other
- Date Received
- September 8, 1995
- Date of Event
- February 1, 1994
- Report Date
- August 28, 1995
- Manufacturer
- CARDIAC PACEMAKERS INC. (CPI)
- Product Code
- LWS
- Report Source
- Voluntary report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT HAD A DEFIBRILLATOR IMPLANTED AFTER AN EPISODE OF SUDDEN DEATH. EP TESTING PROVOKED ONLY VENTRICULAR FIBRILLATION 18 MONTHS THEREAFTER, THE PT HAD HAD NO ICD FIRINGS. WHILE IN A GROCERY STORE, PT WAS LEANING AGAINST AN ELECTRONIC ARTICLE SURVEILLANCE (EAS) DEVICE, WHEN THE ICD FIRED WITHOUT ANY CLINCAL PRODROME. SUBSEQUENT TESTING OF THE ICD VIA THE BEEPER TONE MONITORING FEATURE OF THE DEVICE SHOWED THE ICD DID DETECT HIGH FREQUENCY NOISE WHEN CLOSE TO THE EAS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRX IMPLANTABLE DEFIBRILLATOR | DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS INC. (CPI) | 1705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |