SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2014-05604
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- March 6, 2014
- Report Date
- March 6, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 4196, LEAD, IMPLANTED: (B)(6) 2012; 5076, LEAD, IMPLANTED (B)(6) 2014. (B)(4).
IT WAS REPORTED THE RIGHT ATRIAL (RA) LEAD AND THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE RIGHT ATRIAL (RA) LEAD WAS REPOSITIONED AND AN ATTEMPT TO REPLACE THE LEFT VENTRICULAR (LV) LEAD WAS UNSUCCESSFUL DUE TO PATIENT ANATOMY. CONSEQUENTLY, THE SAME LEFT VENTRICULAR (LV) LEAD WAS USED. ALSO REPORTED WAS THAT THE RIGHT ATRIAL (RA) LEAD DEMONSTRATED LOW P WAVES AND THE RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED A LACK OF R WAVES. ADDITIONALLY, THE PATIENT DEVELOPED AN INFECTION AND THE SYSTEM WAS REMOVED AND REPLACED EXCEPT THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE REPLACED DUE TO PATIENT ANATOMY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341829 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Hospitalization| R |