FDA Adverse Event
Malfunction
Summary report: N
ACUITY
MDR report key: 1863713
·
Received October 11, 2010
Report
- Report Number
- 2124215-2010-15943
- Event Type
- Malfunction
- Date Received
- October 11, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 3, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P050046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED PACING IMPEDANCES RANGING FROM 900 TO GREATER THAN 2000 OHMS. THE PACING THRESHOLD HAS ALSO INCREASED. TECHNICAL SERVICES (TS) ADVISED TO CONSIDER LEAD DISLODGEMENT OR POSSIBLE LOOSE SET SCREW. ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD WAS TESTED AND RESULTS WERE NOTED TO BE FINE. THE LV PACING WAS RECONFIGURED AND THERE WERE NO SYMPTOMS OR ADVERSE EVENTS ASSOCIATED WITH THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | H227| MISMATCH| 0180| 4554 |