FDA Adverse Event
Injury
Summary report: N
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
MDR report key: 2953593
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01175
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- October 30, 2012
- Report Date
- November 6, 2012
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P030036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY AFTER IMPLANT, ABNORMAL BLOOD TESTS REVEALS THAT THE PATIENT DEVELOPED SEPSIS (B)(6) ALONG WITHA FEVER. THE PATIENT HAD A PROLONGED HOSPITAL STAY FOR TREATMENT WITH MEDICATION. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56314 | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 383098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |