FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 1072167
·
Received July 10, 2008
Report
- Report Number
- 2182208-2008-00208
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- December 6, 2007
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ASKU
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS REPLACED DUE TO HIGH IMPEDANCE (1,123 OHMS). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE LEAD WAS EXPLANTED DUE TO INSULATION BREACHES. THE PREVIOUS REPORT OF HIGH IMPEDANCE WAS INCORRECT. NO INFORMATION ON LEAD IMPEDANCE WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6947 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 7275 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |