FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3152326
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06858
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 8, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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. CONCOMITANT MEDICAL PRODUCTS: C154DWK, BI-VENTRICULAR DEFIBRILLATOR, (B)(6) 2008; 4193-88, IMPLANTABLE PACING LEAD, (B)(6) 2008; 4076-52, IMPLANTABLE PACING LEAD, (B)(6) 2008. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD AN APPARENT FRACTURE. IT WAS ALSO REPORTED THAT THE IMPEDANCE WAS GREATER THAN 2000 OHMS AND THE THRESHOLD WAS RISING. THE LEAD WAS CAPPED 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 |
|---|---|---|---|---|---|---|---|
| 252850 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Hospitalization| R |