FDA Adverse Event
Injury
Summary report: N
INGEVITY
MDR report key: 4884630
·
Received July 1, 2015
Report
- Report Number
- 2124215-2015-08291
- Event Type
- Injury
- Date Received
- July 1, 2015
- Date of Event
- May 27, 2015
- Report Date
- May 29, 2015
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVN
- Adverse Event
- Yes
- 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 RIGHT ATRIAL (RA) LEAD HAD DISLODGED AFTER THE PROCEDURE. IT WAS NOTED THAT TWENTY FIVE REVOLUTION WERE REQUIRED TO RETRACT THE HELIX. ALL MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427890 | INGEVITY | IMPLANTABLE LEAD | NVN | GUIDANT PUERTO RICO BV | 7740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |