FDA Adverse Event
Injury
Summary report: N
ACUITY
MDR report key: 3213654
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08078
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 9, 2013
- Report Date
- June 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, PRODUCT ANALYSIS CONFIRMED THAT THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE DISLODGEMENT. VISUAL OBSERVATION NOTED BLOOD OR BODY FLUID IN THE LUMEN. THE LEAD MET SPECIFICATION.
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
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Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. A REPLACEMENT LV LEAD WAS IMPLANTED BY THE PHYSICIAN. THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314228 | ACUITY | IMPLANTABLE HF LEAD | OJX | CPI - DEL CARIBE | 4592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| L| R | 0295| 4473| 4554| 4592| N140 |