N
Patient 1
THE EVENT DATE IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: MODEL: 3189, SCS LEAD, THERAPY DATE: UNKNOWN THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9908449
- MDR report key
- 9908449
- Report number
- 1627487-2020-03499
- Event key
- 0
- Event type
- 3
- 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 | 6880060 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2020-03500. IT WAS REPORTED ONE OF THE PATIENT'S LEADS WAS FOUND TO HAVE MIGRATED. IN TURN, THE LEAD WAS REPOSITIONED VIA SURGICAL INTERVENTION ON MARCH 13, 2020 TO ADDRESS THE ISSUE. NOTE: BOTH OF THE PATIENT'S LEADS ARE BEING REPORTED BECAUSE IT'S UNKNOWN WHICH LEAD WAS REPOSITIONED.