FDA Adverse Event
Death
Summary report: N
SELUTE PICOTIP
MDR report key: 2133456
·
Received June 20, 2011
Report
- Report Number
- 2124215-2011-10571
- Event Type
- Death
- Date Received
- June 20, 2011
- Date of Event
- January 31, 2011
- Report Date
- May 25, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P950001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD REPRESENTATIVE THAT THE (B)(6) WAS NOT DUE TO THE DEVICE. 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 EXPIRED DUE TO A (B)(6) ALONG WITH MULTIPLE SYSTEM FAILURE. THE DEVICE WAS EXPLANTED AT THE MORTUARY. NO PERFORMANCE ISSUES WERE REPORTED AGAINST THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SELUTE PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death | 4053| 1297| 4034 |