FDA Adverse Event
Injury
Summary report: N
SWEET PICOTIP
MDR report key: 2170854
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10819
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- 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 RIGHT ATRIAL LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. DURING A REVISION PROCEDURE, THE PHYSICIAN OBSERVED THAT THE LEAD WAS FRACTURED AT THE LEVEL OF THE CLAVICLE. THE PHYSICIAN SURGICALLY ABANDONED THIS LEAD AND ANOTHER LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
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 | Life Threatening| R |