FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 2810690
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15659
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 DURING A DEVICE CHECK, IT WAS NOTED THAT THE RHYTHM WAS P-WAVE FOLLOWED BY R-WAVE, BUT THE DEVICE UNDERSENSED THE ATRIAL EVENT AND THE ATRIAL PACING RESULTED IN VENTRICULAR CAPTURE. AN ATRIAL LEAD DISLODGMENT WAS SUSPECTED. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. IT WAS SUSPECTED THAT THE ATRIAL LEAD DISLODGEMENT WAS AFFECTING THE RIGHT VENTRICULAR (RV) LEAD. BOTH LEADS REMAIN IN USE. NO FURTHER 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Life Threatening | D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |