FDA Adverse Event
Death
Summary report: N
SWEET PICOTIP
MDR report key: 1722443
·
Received June 14, 2010
Report
- Report Number
- 2124215-2010-12302
- Event Type
- Death
- Date Received
- June 14, 2010
- Date of Event
- June 8, 2010
- Report Date
- June 8, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS PATIENT WAS DIAGNOSED WITH AN INFECTION, AND PASSED AWAY DURING A SUBSEQUENT SURGICAL ATTEMPT TO EXTRACT THE ASSOCIATED LEADS. IT WAS REPORTED THE PATIENT¿S SUPERIOR VENA CAVA WAS TORN DURING THE USE OF THE LEAD EXTRACTION TOOL. THERE WERE NO ALLEGATIONS AGAINST THIS LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWEET PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death | N119| 0157| 4543| 4054 |