FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2955217
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-00818
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 13, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 PRODUCT: 7288 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2006. (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 DURING PROPHYLACTIC LASER REMOVAL OF A RIGHT VENTRICULAR (RV) LEAD THE PATIENT EXPERIENCED MYOCARDIAL PERFORATION AND A DROP IN BLOOD PRESSURE. PATIENT HAD EMERGENCY CHEST SURGERY AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS REQUIRED FOR STABILIZATION. THE LEAD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58289 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Hospitalization| L| R | 1688TC COMPETITOR IMPLANTABLE PACING LEAD |