FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2953013
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00851
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 21, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2006 (B)(6), 4193 IMPLANTABLE PACING LEAD 2006 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INFECTION OCCURRED. THE PATIENT WAS GIVEN ANTIBIOTIC TREATMENT FOR ENDOCARDITIS AND SEPSIS. THE IMPLANTABLE PULSE GENERATOR SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56741 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Hospitalization| L| R | (B)(4) IMPLANTABLE CARDIOVERT DEFIBRILLATOR |