FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 4163146
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12448
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 23, 2014
- Report Date
- July 23, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Removal / Correction Number
- Z-0070-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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: 5076-52 IMPLANTABLE PACING LEAD, (B)(6) 2006; A 5071-35 IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE RIGHT ATRIAL (RA) LEAD HAD NOISE AND A FRACTURE AT THE CLAVICLE/FIRST RIB JUNCTION DUE TO CLAVICULAR CRUSH. BOTH LEADS WERE EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 643610 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR | Hospitalization| R | D274TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |