FDA Adverse Event
Other
Summary report: N
GOODMAN CO LTD
MDR report key: 812450
·
Received January 11, 2007
Report
- Report Number
- 2243801-2006-00028
- Event Type
- Other
- Date Received
- January 11, 2007
- Date of Event
- October 4, 2006
- Report Date
- January 2, 2007
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED FOR EVAL. THE RETURNED UNIT DID NOT PASS PROXIMAL CONTINUITY TESTING. INVESTIGATION OF THE PROXIMAL ELECTRODE REVEALED THE PROXIMAL WIRE WAS DISCONNECTED. THERE WAS EVIDENCE THAT THE PROXIMAL WIRE WAS SOLDERED ENOUGH INSIDE THE ELECTRODE. MICROSCOPIC INVESTIGATION OF THE PROXIMAL WIRE SHOWED THAT THE PROPER AMOUNT (APPROXIMATELY 1.5MM FROM THE END OF THE WIRE) WAS SOLDERED INTO THE ELECTRODE. THIS DISCONNECTION MAY HAVE OCCURRED DURING MANIPULATION OF THE CATHETER UNITS. HOWEVER, NO SPECIFIC CONCLUSIONS CAN BE DRAWN.
Description of Event or Problem · 1
AFTER INSERTION OF A PACING CATHETER, UNABLE TO OBTAIN SENSING MEASUREMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOODMAN CO LTD | BIPOLAR PACING CATHETER, PUR | DYB | B. BRAUN MEDICAL, INC. | NA | 60840518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |