N
Patient 1
DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9908604
- MDR report key
- 9908604
- Report number
- 1627487-2020-03501
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-11
- Date received
- 2020-03-31
- 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 | OCTRODE LEAD KIT, 90CM LENGTH | SCS LEAD | ST. JUDE MEDICAL - NEUROMODULATION | LGW | 3189 | 3189 | 5085162 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
DEVICE 1 OF 4: RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03502. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03503. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03504. IT WAS REPORTED THE PATIENT UNDERWENT EXPLANT OF SCS SYSTEM FOR UNKNOWN REASON ON (B)(6) 2020. FURTHER INFORMATION REVEALED THE PATIENT WAS NO LONGER USING THE SYSTEM, BUT FURTHER DETAILS WERE UNABLE TO BE OBTAINED.
N
Patient 1
FURTHER INFORMATION REVEALED THAT THE PATIENT NEEDED AN MRI AND A PACEMAKER, MAKING EXPLANT OF THE SCS SYSTEM ELECTIVE. AS THE EXPLANT WAS ELECTIVE, IT DOES NOT MEET REPORTABILITY CRITERIA.