N
Patient 1
MAUDE MDR 7047370
- MDR report key
- 7047370
- Report number
- 3007566237-2017-04895
- Event key
- 0
- Event type
- 3
- Date received
- 2017-11-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NURO | STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION | MEDTRONIC NEUROMODULATION | NAM | 3533 | 3533 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-11-20 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE PATIENT REPORTED THAT THEIR PERCEPTION OF THERAPY FOR AFTER THEIR 9TH SESSION WAS THAT THEY WERE WORSE THAN BEFORE AND STILL WERE. THEY WERE HURTING IN THEIR BLADDER REGION. IT WAS ALSO PROVIDED THAT THEY GOT AN INFECTION, AND WERE CURRENTLY ON ANTIBIOTICS. THE PATIENT HAD COMPLETED 12 SESSIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT SINCE COMPLETED THE 12 TREATMENTS, THEIR SYMPTOMS HAD GONE BACKWARDS. THEY STATED THAT THEY WERE EXPERIENCING THEIR OLD PROBLEM OF PAINFUL URINATING. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.