FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 2171556
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-09764
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- May 31, 2011
- Report Date
- September 22, 2011
- 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
UPON RECEIPT AT OUR POST QUALITY ASSURANCE LABORATORY A FRACTURE OF THE OUTER COILS WAS CONFIRMED. DUE TO THE LOCATION AND THE TYPE OF DAMAGE IT IS POSSIBLE THAT THE DAMAGE MOST LIKELY WAS DUE TO CLAVICLE FIRST RIB CRUSH. THE FINDINGS IN THE LABORATORY COULD HAVE CONTRIBUTED TO THE CLINICAL OBSERVATIONS.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD AND LEFT VENTRICULAR LEAD WERE EXPLANTED DUE TO A DISLODGEMENT. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR LEAD SHOWED A CHANGE IN PACING IMPEDANCES. THE LEADS WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE PROCEDURE.
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 | Required Intervention |