FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO
MDR report key: 2053035
·
Received April 13, 2011
Report
- Report Number
- 2649622-2011-05745
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLDS. THE PHYSICIAN SUSPECTS A DISLODGEMENT OF THE LEAD. THE PHYSICIAN HAS DECIDED TO FOLLOW THE PATIENT MORE CLOSELY AND AN INTERVENTION IS NOT PLANNED AT THE PRESENT TIME. THE LEAD IS STILL 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 | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other | 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 7298 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |