FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3051170
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04842
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- October 30, 2012
- Report Date
- November 6, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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. PRODUCT ID (B)(4), IMPLANTED: (B)(6) 2011; PRODUCT ID 5076-52, IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. BACTEREMIA WITH VEGETATIVE GROWTH ON THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED. IT WAS FURTHER REPORTED THAT THE PATIENT COMPLAINED OF NECK PAIN AND HEADACHE. "MENTAL STATUS CHANGES" WERE NOTED. THE SYSTEM WAS REPLACED. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152857 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | Hospitalization| R |