N
Patient 1
MAUDE MDR 6539186
- MDR report key
- 6539186
- Report number
- 3012165443-2017-00017
- Event key
- 0
- Event type
- 3
- Date received
- 2017-05-02
- 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 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-02 | 0 | 1. H |
Event Narratives#
D
Patient 1
A PATIENT REPORTED THEY MISSED THEIR 8TH PTNM SESSION ON (B)(6) 2017 BECAUSE THEY WERE IN THE HOSPITAL. THEY HAD PAINS IN THE CHEST AND THEIR BLOOD PRESSURE WAS LOW AND THEY WERE HAVING CHEST SPASMS. THEY WENT TO SEE A CARDIOLOGIST THE DAY PRIOR TO THE REPORT FOR HEART SPASMS AND THEY WERE UNSURE OF WHAT WAS CAUSING IT. THEY WERE NOT FEELING ANY BETTER ON THE DAY OF THE REPORT, AND THEY COULD NOT WALK. THEIR LEFT LEG WAS SO SWOLLEN. THE HEALTHCARE PROVIDER (HCP) WAS AWARE OF THE ISSUE, BUT THEY WERE NOT SURE WHAT THEY WERE GOING TO DO. THE PATIENT STATED THAT THE HCP'S SAID THEY WERE DEHYDRATED BECAUSE THEY WERE NOT DRINKING ENOUGH. THE PATIENT NOTED THEY HAD GOUT AND THEY WERE ON MEDICATION FOR IT. THEY WERE ALSO TAKING MEDICATION FOR URINARY SYMPTOMS. THE PATIENT BEGAN THEIR PTNM THERAPY SESSIONS ON (B)(6) 2017. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
N
Patient 1
PRODUCT PROBLEM IS NO LONGER APPLICABLE TO THIS EVENT. 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.
N
Patient 1
IT WAS INITIALLY REPORTED THAT THE PATIENT HAD 1 PTNM SESSION. THIS INFORMATION WAS INCORRECT.
D
Patient 1
THE PATIENT HAD COMPLETED 11 PERCUTANEOUS TIBIAL NEUROMODULATION SESSIONS.
N
Patient 1
AFTER REVIEW, PATIENT CODES (B)(4) NO LONGER APPLY TO THIS EVENT. REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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.
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.
D
Patient 1
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT THEY HAD BEEN IN AND OUT OF THE HOSPITAL. THEY WERE HAVING PROBLEMS WITH THEIR HEART, AND WERE ON TWO DIFFERENT TYPES OF MEDICATIONS. THEIR PERCEPTION OF THERAPY WAS A 5 DUE TO HAVING TEN HERNIA OPERATIONS ON THEIR RIGHT SIDE AS WELL AS A TESTICLE REMOVED. THE PATIENT FURTHER PROVIDED THAT THEY HAD "A PROBLEM." THE PATIENT HAD COMPLETED 1 PERCUTANEOUS TIBIAL NEUROMODULATION 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.