FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 1792253
·
Received August 10, 2010
Report
- Report Number
- 2649622-2010-07063
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- May 3, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE INTERROGATION, IT WAS DETERMINED THAT THERE WAS NO RIGHT VENTRICULAR CAPTURE, THE LEFT VENTRICULAR PACES WERE BEING SEEN IN THE RIGHT VENTRICLE, AND THE DEVICE WAS DOUBLE COUNTING DUE TO NO CAPTURE. THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS CAPPED, AND AN OLDER RIGHT VENTRICULAR PACING LEAD IS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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 | 85 YR | Other| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD |