FDA Adverse Event
Malfunction
Summary report: N
2124215-2014-16429
MDR report key: 4140056
·
Received October 3, 2014
Report
- Report Number
- 2124215-2014-16429
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- June 27, 2014
- Report Date
- September 9, 2014
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PHYSICIAN TOLD A FIELD REPRESENTATIVE AT A CONFERENCE THAT THERE WERE FOUR OR FIVE INSTANCES WHERE THE DF-4 LEAD DID NOT FIT INTO THE MEDTRONIC EVIA HEADER. NO FURTHER INFORMATION WAS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620785 | NVY | GUIDANT PUERTO RICO BV | TACHY LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | MISMATCH| 0296| F103 |