N
Patient 1
MAUDE MDR 6453611
- MDR report key
- 6453611
- Report number
- 3007566237-2017-01242
- Event key
- 0
- Event type
- 3
- Date received
- 2017-04-03
- 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 | ADVANCED URO-SOLUTIONS, L.L.C. | NAM | 3533 | 3533 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-04-03 | 0 | 1. R |
Event Narratives#
D
Patient 1
A PATIENT REPORTED THAT THEIR URINARY INCONTINENCE WAS WORSE THAN BEFORE. THEY ALSO STATED THAT THEY FELL ON (B)(6) 2017 AND HAD BEEN HAVING KNEE SWELLING SINCE. THE PATIENT MENTIONED THEY SAW THEIR HEALTHCARE PROVIDER ON (B)(6) 2017 AND THEY ADVISED THE PATIENT TO USE ICE TO REDUCE THE SWELLING. THE PTNM THERAPY SESSIONS BEGAN ON (B)(6) 2017. IT WAS NOTED THAT THE PATIENT HAS A PAST MEDICAL HISTORY OF RHEUMATOID ARTHRITIS. FOLLOW UP FROM THE HEALTHCARE PROVIDER, ON (B)(6) 2017, NOTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AT THE START OF TREATMENT AND THEY WERE TREATED FOR THE UTI ON (B)(6) 2017. THE HCP NOTED THAT PER THE STAFF AT THE PATIENT'S HOME, THEY PATIENT HAS A HISTORY OF KNEE/JOINT PAIN. THEY WERE UNAWARE OF THE SYMPTOMS WORSENING AND THE PATIENT FALLING. NO FURTHER COMPLICATIONS ARE ANTICIPATED.
N
Patient 1
D
Patient 1
ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER REPORTED THAT THE CAUSE OF THE URINARY TRACT INFECTION WAS UNKNOWN. THEY STATED THAT THEY COULD NOT SAY THAT THE PTNM DEVICE OR THERAPY CAUSED THE UTI, WORSENED SYMPTOMS OR FALL. THE STAFF AT THE PATIENT'S HOME FACILITY STATED THAT THE PATIENT HAD MULTIPLE FALLS AND LEG PAIN PRIOR TO THE PTNM THERAPY. THE PATIENT DOES HAVE ASSISTANCE FROM HOME CARE STAFF WITH TRANSFERS WHEN THEY COME TO THEIR VISITS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
ANALYSIS OF THE NURO DEVICE (B)(4) FOUND NO ANOMALIES. THE DEVICE PASSED ALL FUNCTIONAL TESTING. 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.