FDA Adverse Event
Injury
Summary report: N
SWEET PICOTIP
MDR report key: 1864082
·
Received October 11, 2010
Report
- Report Number
- 2124215-2010-15970
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- August 4, 2010
- Report Date
- August 4, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AVAILABLE INFORMATION SUGGESTS THAT THIS RA LEAD WAS DISCARDED AFTER THE PROCEDURE, AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. A REQUEST WAS MADE TO HAVE THE EXPLANTED DEVICE RETURNED. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TRANSVENOUS RIGHT ATRIAL (RA) LEAD WERE EXPLANTED DUE TO A SYSTEM INFECTION. OF NOTE, A COMPETITIVE RIGHT VENTRICULAR LEAD WAS ALSO EXPLANTED AT THE TIME.
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 | 54 YR | Life Threatening| R | 4054| E110| 1853| 6945| T125 |