FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 3991226
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08241
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 20, 2014
- Report Date
- May 20, 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
- MN, US
- Reporter Occupation
- OTHER
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: 5076-45 LEAD 2007-(B)(6), (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING (TWOS). THE RV LEAD 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 |
|---|---|---|---|---|---|---|---|
| 468119 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694958 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| L| R | D154AWG ICD 2007-(B)(6) |