FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3212537
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08780
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 21, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION CONFIRMED A FRACTURE 350MM FROM THE TERMINAL PIN. DUE TO THE LOCATION OF THE FRACTURE, THIS WAS CONSISTENT WITH A FATIGUE FRACTURE NEAR THE SUTURE SLEEVE TIE DOWN AREA.
Additional Manufacturer Narrative · 1
UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
-
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE NORMAL REPLACEMENT PROCEDURE IT WAS NOTED THAT THIS LEFT VENTRICULAR LEAD WAS FRACTURED. THE LEAD WAS EXPLANTED AND WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313691 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |