FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 1991203
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-02286
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT ALERT WAS TRIGGERED DUE TO HIGH IMPEDANCE, AND AN APPARENT LEAD FRACTURE ON THE RIGHT VENTRICULAR LEAD. A NEW LEAD WAS PLACED. THE PACE/SENSE AND RIGHT VENTRICULAR COILS WERE CAPPED AND REPLACED WHILE THE SUPERIOR VENA CAVA PORTION REMAINS IN USE. 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 | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |