FDA Adverse Event
Injury
Summary report: N
2124215-2010-14582
MDR report key: 1851984
·
Received October 4, 2010
Report
- Report Number
- 2124215-2010-14582
- Event Type
- Injury
- Date Received
- October 4, 2010
- Date of Event
- July 12, 2010
- Report Date
- July 12, 2010
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. A LEAD REVISION WAS PERFORMED WHERE THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DTB | GUIDANT PUERTO RICO BV |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Life Threatening| R | 4087| 1298| 4088| S603 |