FDA Adverse Event
Injury
Summary report: N
SWEET PICOTIP
MDR report key: 2172828
·
Received July 22, 2011
Report
- Report Number
- 2124215-2011-10681
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 PRODUCT WAS PART OF SURGICAL INTERVENTION TAKEN DUE TO POCKET EROSION. THE POCKET WAS OPENED, THE EXISTING LEADS WERE REPOSTITIONED AND A NEW PACEMAKER WAS IMPLANTED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWEET PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4053 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | 4053| 1298| 4034 |