FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 1792682
·
Received August 11, 2010
Report
- Report Number
- 2649622-2010-07059
- Event Type
- Injury
- Date Received
- August 11, 2010
- Date of Event
- April 20, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
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. DEVICE MODEL AND SERIAL NUMBER ADDED (INITALLY SENT AS UNKNOWN).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE HAD BEEN 249 SHORT INTERVAL COUNTS MEASURED IN THE PAST 5 MONTHS AND NO EPISODES WITH EGM. THE LEAD REMAINS IN USE AT THIS TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6947 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |