FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 4220971
·
Received November 3, 2014
Report
- Report Number
- 2124215-2014-19242
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- August 2, 2014
- Report Date
- August 2, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATIONS INDICATES THAT A COMPLETE LEAD WAS RETURNED. THE SPIRAL FIXATION AND TIP SECTION OF LEAD WAS NORMAL AS THERE WAS NO SIGNS OF DAMAGE OR DEFECT OBSERVED. THERE WAS NO DEFECTS NOTED AT THE LEAD'S TIP THAT WOULD HAVE CONTRIBUTED TO THE DISLODGEMENT.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS DISLODGED THE DAY AFTER IMPLANT. THE PRODUCT WAS EXPLANTED. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702677 | ACUITY | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization| L| R | 4554| 0276| 4137| 4135| N160| 0275| 4555| 4136| K063 |