SELECT SECURE
Report
- Report Number
- 2649622-2013-02509
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 22, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P030036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
PRODUCT EVENT SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS BLOOD ON THE DISTAL ELECTRODE.
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE LEAD DISLODGED. IT WAS FURTHER REPORTED THAT THERE WAS TISSUE IN THE HELIX. THE TISSUE WAS REMOVED AND ATTEMPTED TO REIMPLANT BUT AFTER A FEW LOCATION ATTEMPTS IT WAS DECIDED TO USE A DIFFERENT LEAD. THE LEAD WAS REMOVED AND A NEW LEAD IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT THE LEAD DISLODGED. IT WAS FURTHER REPORTED THAT THERE WAS TISSUE IN THE HELIX. THE TISSUE WAS REMOVED AND ATTEMPTED TO REIMPLANT BUT AFTER A FEW LOCATION ATTEMPTS IT WAS DECIDED TO USE A DIFFERENT LEAD. THE LEAD WAS REMOVED AND A NEW LEAD IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98099 | SELECT SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 383059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00009 YR |