N
Patient 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 6630816
- MDR report key
- 6630816
- Report number
- 2649622-2017-07505
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-06-07
- Date received
- 2017-06-09
- 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
- LISA WOODWARD CLARK
- Address
- 7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-09 | 0 |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THE LEAD SEEMED MORE STIFF THAN THE OTHERS IMPLANTED THAT DAY. WHEN THE IMPEDANCES WERE CHECKED DURING IMPLANT ELECTRODE 3 SHOWED OUT OF RANGE LOW < 50. THE HEALTHCARE PROFESSIONAL (HCP) THEN PULLED THE ELECTRODE OUT OF THE EXTENSION AND WIPED IT OFF TWICE. THEY NOTICED THERE WAS A SMALL WIRE COMING OUT OF THE LEAD BY THE ELECTRODE. THEY THEN PLACED THE LEAD BACK IN THE EXTENSION AND DID THE TEST AGAIN IN THAT ELECTRODE THEN SHOWED OVER 10 ,000. THE HCP DID NOT WANT TO REMOVE THE LEAD FROM THE EXTENSION ANOTHER TIME AND THEY FELT IT WOULD DAMAGE THE INTEGRITY OF THE LEAD EVEN MORE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.
N
Patient 1
FDD (B)(4) NO LONGER APPLIES.
N
Patient 1
(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.