FDA Adverse Event
Other
Summary report: N
GOODMAN CO. LTD
MDR report key: 812437
·
Received January 11, 2007
Report
- Report Number
- 2243801-2006-00025
- Event Type
- Other
- Date Received
- January 11, 2007
- Date of Event
- December 7, 2006
- Report Date
- January 5, 2007
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- DYB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MFR FOR EVAL. VISUAL INSPECTION OF THE RETURNED UNIT INDICATES THAT THE UNIT WAS NOT USED IN VIVO. THE UNIT DID NOT PASS PROXIMAL CONTINUITY TESTING. MICROSCOPIC INVESTIGATION OF THE PROXIMAL ELECTRODE DISCOVERED THAT THE PROXIMAL WIRE WAS NOT SOLDERED COMPLETELY. MINIMAL SOLDER IS EVIDENT AND THEREFORE, DURING MANIPULATION CONTRIBUTED TO DISCONNECTION.
Description of Event or Problem · 1
PACING FAILURE. NO RESPONSE FROM PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOODMAN CO. LTD | PACING CATHETER | DYB | B. BRAUN MEDICAL, INC. | NA | 60766684 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |