FDA Adverse Event
Injury
Summary report: N
SELUTE PICOTIP
MDR report key: 3913516
·
Received July 3, 2014
Report
- Report Number
- 2124215-2014-12371
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- May 29, 2014
- Report Date
- May 29, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P950001
- 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 PATIENT WITH RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. A DECISION WAS LATER MADE THAT THIS NOISE WAS BROUGHT ABOUT BY LEAD FRACTURE. THIS LEAD WAS THEN EXPLANTED THROUGH LASER EXTRACTION. THEREAFTER, A NEW COMPETITOR LEAD WAS SUCCESSFULLY EMPLOYED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391439 | SELUTE PICOTIP | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 4063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| L| R | 4261| 4063| 1230| 0446 |