FDA Adverse Event
Injury
Summary report: N
AXIUM¿
MDR report key: 8903150
·
Received August 16, 2019
Report
- Report Number
- 1627487-2019-09352
- Event Type
- Injury
- Date Received
- August 16, 2019
- Date of Event
- July 29, 2019
- Report Date
- August 28, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- PMP
- UDI-DI
- 05415067027146
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Additional Manufacturer Narrative · 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE ON (B)(6) 2019 THE PHYSICIAN WAS UNABLE TO IMPLANT THE DRG LEAD DUE TO PATIENT ANATOMY. AS A RESULT, THE PROCEDURE WAS ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695446 | AXIUM¿ | DRG LEAD | PMP | ST. JUDE MEDICAL - NEUROMODULATION | MN10350-90A | 6853902 | 05415067027146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |