FDA.reportPublic FDA data

MAUDE MDR 6504575

MDR report key
6504575
Report number
3007566237-2017-01488
Event key
0
Event type
3
Date of event
2017-03-15
Date received
2017-04-19
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 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 table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NUROSTIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTIONMEDTRONIC NEUROMODULATIONNAM35333533* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-1901. O

Event Narratives#

N

Patient 1

D

Patient 1

A PATIENT REPORTED THAT THE FIRST FOUR SESSIONS OF THEIR PTNM THERAPY SESSIONS WERE GOOD AND THEN THE 5TH ONE WAS TERRIBLE. THEY HAD TO DISCONTINUE THE TREATMENTS. DURING THE FIFTH TREATMENT, THEY HAD A LOT OF PAIN DURING AND AFTER THE "INJECTION". THE BOTTOM ON THEIR FOOT HURT SINCE THEN FOR AT LEAST TWO WEEKS. THEY HAD SEVERE PAIN AND SPASMS UP THEIR LEGS AND STILL HAS SPASMS ONCE OR TWICE A DAY ON THEIR UPPER LEG. THEY GET UP IN THE MORNING AND HAVE A LOT OF PAIN IN THEIR LEG, AND THEN AGAIN BEFORE THEY GO TO BED AT NIGHT. THEY HAVE PAIN. THEIR LAST PTNM TREATMENT WAS ON (B)(6) 2017 AND THAT FOLLOWING MONDAY THEY WENT INTO THE ER FOR BRONCHITIS/ASTHMA ATTACK. THEY COULD NOT BREATHE AND THEY WERE COUGHING ALL THE TIME. THEY WERE PLACED ON OXYGEN. THE FOLLOWING FRIDAY, THEY WENT INTO THE HOSPITAL AND WAS THERE UNTIL ABOUT A WEEK AGO. AN ULTRASOUND SHOWED SOME BLOOD CLOT AREAS, BUT NOTHING TO PINPOINT THE PROBLEM. THEY STATED THAT THEIR BLADDER WAS TERRIBLE AGAIN AND THEY HAD NO CONTROL. THE PATIENT STATED THEY HAD BEEN ON MANY ANTIBIOTICS AND THEY WERE NOT SURE IF THAT HELPED, BUT THEY WERE FEELING BETTER. THEY WERE DOING PHYSICAL THERAPY, STILL WEARING 5 PADS PER NIGHT AND WHEN THEY WAKE UP IN THE MORNING THE PAD IS SOAKED. THE PATIENT WOULD FOLLOW UP WITH THEIR HCP. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

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.