ACUITY
Report
- Report Number
- 2124215-2010-24244
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 15, 2010
- Report Date
- January 10, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
THIS LEAD IS UNDERGOING ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD EXPERIENCES SEVERE COUGHING SPELLS. A COUGHING SPELL CAUSED THE LV LEAD TO DISLODGE. THE THRESHOLD MEASUREMENTS HAVE ALSO INCREASED AND THERE IS DIAPHRAGMATIC STIMULATION IN ALL CONFIGURATIONS. A REVISION PROCEDURE WAS SCHEDULED TO PLACE AN EPICARDIAL LEAD DUE TO THE PATIENT'S SEVERE COUGHING ATTACKS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION INDICATED THAT THIS LEAD WAS EXPLANTED DUE TO BEING UNABLE TO PROGRAM AROUND DIAPHRAGMATIC STIMULATION. THE LEAD WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |