FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3051100
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04732
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- February 4, 2013
- Report Date
- February 4, 2013
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE HELIX WAS FOUND TO BE BENT. IT WAS NOTED THAT THE HELIX WAS DAMAGED AT IMPLANT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153826 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR |