FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 3152253
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-05509
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 5, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. (B)(4). CONCOMITANT PRODUCTS: D314DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: (B)(6) 2012; 5076-52 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2005.
Description of Event or Problem · 1
IT WAS REPORTED A PATIENT ALERT WAS TRIGGERED AND THAT THERE WAS AN APPARENT FRACTURE OF THE VENTRICULAR LEAD. DURING LEAD REPLACEMENT, THE POCKET WAS FOUND TO BE RED AND POSSIBLY INFECTED. THE LEAD WAS REMOVED 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 |
|---|---|---|---|---|---|---|---|
| 252822 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Hospitalization| R |