FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 2953742
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01323
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- May 8, 2012
- Report Date
- November 16, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
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: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4). CONCOMITANT PRODUCTS: 4076 IMPLANTABLE PACING LEAD 2012 (B)(6); 4196 IMPLANTABLE PACING LEAD 2012 (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED AN INFECTION OCCURRED. THE DEVICE AND LEADS WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56696 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MEDTRONIC PUERTO RICO OPERATIONS CO | 6947M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |