FDA Adverse Event
Injury
Summary report: N
SPRINT FIDELIS
MDR report key: 2791241
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14214
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S029
- Removal / Correction Number
- Z-0070-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS RISING IMPEDANCE ON A RIGHT VENTRICULAR LEAD. THE LEAD IS STILL IN USE AND THE CLINIC IS MONITORING THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN NOTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS RISING IMPEDANCE ON A RIGHT VENTRICULAR LEAD. IT WAS FURTHER REPORTED THAT THERE WAS INCREASED THRESHOLD. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN NOTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT FIDELIS | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| O| R | D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD |