FDA Adverse Event
Injury
Summary report: N
SWEET PICOTIP
MDR report key: 3052662
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04636
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 5, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 THE PATIENT IMPLANTED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ADMITTED TO THE EMERGENCY ROOM AFTER RECEIVING SEVERAL SHOCKS. THE DEVICE WAS CHECKED AND WAS FOUND UNABLE TO CAPTURE WITH PACING. THE PATIENT HAD A SIGNIFICANT WEIGHT LOST AND THE DEVICE HAD MIGRATED. THE LEADS APPEARED TO HAVE DISLODGED AND THE PACING AND SHOCK IMPEDANCES WERE OUT OF RANGE. THE ENTIRE SYSTEM WAS EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154555 | SWEET PICOTIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | 1861| 430-07| T165| 292-03| T180| 0148| 4054 |