SPRINT QUATTRO
Report
- Report Number
- 2649622-2013-02106
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- November 28, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4195 IMPLANTABLE PACING LEAD (B)(6) 2008; C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2008. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT EVENT SUMMARY (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.
IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION. THE RIGHT AND LEFT VENTRICULAR LEADS WERE ALSO CAPPED DUE TO HIGH THRESHOLDS. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE DEVICE HAD EARLY BATTERY DEPLETION. THE RIGHT AND LEFT VENTRICULAR LEADS WERE ALSO CAPPED DUE TO HIGH THRESHOLDS. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67993 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD |