FDA Adverse Event
Malfunction
Summary report: N
ACUITY
MDR report key: 3211283
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08510
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 9, 2013
- Report Date
- May 15, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- PMA / PMN Number
- P050046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 HAD TRIPPED AND FELL ON THEIR SIDE. WHEN THE PATIENT PRESENTED A CHEST X-RAY INDICATED A FRACTURE IN THE LEFT VENTRICULAR (LV) LEAD. A WEEK LATER, A DEVICE CHECK NOTED THAT ALL LEAD PARAMTERS WERE STABLE. AS A RESULT, THE PATIENT WILL BE MONITORED EVERY THREE MONTHS UNTIL THE DEVICE CHANGE OUT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311497 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | 4555| M177| 0185| 4480 |