FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3040804
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-04192
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 7, 2013
- Report Date
- April 2, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED WHEN FURTHER INFORMATION IS RECEIVED.
Additional Manufacturer Narrative · 1
THIS LEAD WAS RETURNED FOR ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS ANALYZED AND NO ISSUES COULD BE FOUND. THE LEAD WAS FOUND TO BE WITH IN SPECIFICATION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD (LV) DISPLAYED HIGH THRESHOLDS AND LOSS OF CAPTURE THREE DAYS POST IMPLANT. FURTHER INVESTIGATION FOUND THAT THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE EFFECTS WERE REPORTED.
Description of Event or Problem · 1
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143124 | ACUITY | IMPLANTABLE HF LEAD | OJX | CPI - DEL CARIBE | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |