FDA Adverse Event
Other
Summary report: N
GOODMAN CO. LTD
MDR report key: 926727
·
Received March 29, 2007
Report
- Report Number
- 2243801-2007-00011
- Event Type
- Other
- Date Received
- March 29, 2007
- Date of Event
- February 13, 2007
- Report Date
- March 23, 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 TO BE EVALUATED. THE RETURNED UNIT DID NOT PASS PROXIMAL CONTINUITY TESTING. THE PROXIMAL WIRE IS DISCONNECTED FROM PROXIMAL ELECTRODE. HOWEVER, SOLDER IS EVIDENT. THE PROXIMAL WIRE MAY HAVE DISCONNECTED FROM THE ELECTRODE DURING HANDLING. THIS INCIDENT MAY ALSO BE ATTRIBUTED TO THE UNIT BEING PASSED THROUGH A TIGHT INTRODUCER. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.
Description of Event or Problem · 1
PACING FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOODMAN CO. LTD | PACING CATHETER | DYB | B. BRAUN MEDICAL, INC. | NA | 60759225 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |