FDA Adverse Event
Injury
Summary report: N
BLOOM DTU-215A STIMULATOR SYSTEM
MDR report key: 38301
·
Received September 11, 1996
Report
- Report Number
- 1418957-1996-00001
- Event Type
- Injury
- Date Received
- September 11, 1996
- Date of Event
- August 12, 1996
- Report Date
- September 11, 1996
- Manufacturer
- FISCHER IMAGING CORP.
- Product Code
- JOQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING AN EP STUDY FOR SVT/RF ABLATION, THE STIMULATOR REPORTEDLY MALFUNCTIONED DELIVERING OUTPUT AT AN INTERVAL OF APPROX. 8MSEC. PT DEVELOPED VENTRICULAR TACHYCARDIA WHICH CEASED UPON DISCONNECTION OF THE STIMULATOR. NO FURTHER TREATMENT WAS REQUIRED. NO SUBSEQUENT ADVERSE EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOOM DTU-215A STIMULATOR SYSTEM | EXTERNAL PROGRAMMABLE PULSE GENERATOR | JOQ | FISCHER IMAGING CORP. | DTU-215A/RSIU | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |