FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 4161592
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11490
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 5, 2014
- Report Date
- August 5, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Removal / Correction Number
- Z-0068-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 MEDICAL PRODUCTS: A 4076 LEAD, IMPLANTED: (B)(6) 2005. (B)(4).
Description of Event or Problem · 1
THE PATIENT CALLED AND REPORTED THAT THE LEAD HAD CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING AND NOISE DUE TO A LEAD FRACTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 641890 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Hospitalization| R | D314DRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |