FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 3053283
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05421
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- January 24, 2013
- Report Date
- March 11, 2013
- Manufacturer
- HISTORICAL CPI ST. PAUL
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155537 | UNKNOWN | IMPLANTABLE LEAD | DTB | HISTORICAL CPI ST. PAUL | 4312 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | 4312| E102| 6931| 1857| 6162| 1746| 1600| 0041| 1550 |