FDA Adverse Event
Injury
Summary report: N
2124215-2011-06187
MDR report key: 2060064
·
Received April 15, 2011
Report
- Report Number
- 2124215-2011-06187
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- March 31, 2011
- Report Date
- March 31, 2011
- 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 THE PATIENT FELL AND POSSIBLY BROKE HIS HIP. A CLAVICULAR CRUSH IS SUSPECTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) STATED THAT THERE IS A CONCERN OVER POSSIBLE PACING INHIBITION DUE TO NOISE. THE SR NOTED THAT THE PATIENT CANCELLED HIS APPOINTMENT AND RESCHEDULED FOR THE FOLLOWING WEEK. AT THIS TIME THE SR DOES NOT HAVE SPECIFIC PATIENT INFORMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NVY | GUIDANT PUERTO RICO BV | TACHY LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |