N
Patient 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. EVENT DATE IS AN ESTIMATION.
MAUDE MDR 9889720
- MDR report key
- 9889720
- Report number
- 1627487-2020-03359
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-09
- Date received
- 2020-03-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ANDREA DEITZ
- Address
- 6901 PRESTON ROAD PLANO TX 75024 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | ST. JUDE MEDICAL - NEUROMODULATION | PMP | MN10450-50A | MN10450-50A | 7234788 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 | 1. O |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT'S S1 LEAD HAD MIGRATED FOLLOWING A FALL. X-RAYS CONFIRMED THAT THE LEAD HAD PULLED OUT OF THE EPIDURAL SPACE. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2020. THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.
N
Patient 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.