FDA.reportPublic FDA data

MAUDE MDR 9908163

MDR report key
9908163
Report number
3004209178-2020-06477
Event key
0
Event type
3
Date of event
2020-03-01
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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 table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTELLISSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEFMEDTRONIC PUERTO RICO OPERATIONS CO.LGW9771597715* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT?S INS WAS NOT WORKING AT ALL, WHICH WAS CLARIFIED FURTHER TO MEAN THE INS WAS NOT PROVIDING THEM RELIEF. THE PATIENT STATED THAT THE INS WAS NOT STOPPING THE SPASMS AND THE INS WAS SHOCKING THEM LIKE CRAZY. THE PATIENT NOTED TRYING GROUP A, B AND C THAT THEY HAD AVAILABLE. THE PATIENT STATED THAT THE LAST TIME THEY CHARGED THE INS AND STOPPED USING THE INS WAS THIS MONTH, (B)(6) 2020. THE PATIENT WAS CALLING IN FOR ASSISTANCE WITH ACCESSING MRI MODE. PATIENT SERVICES BEGAN WALKING THE PATIENT THROUGH ACCESSING MRI MODE WHEN THE PATIENT SAW THE ?NO DEVICE FOUND? ERROR MESSAGE ON THE CONTROLLER. PATIENT SERVICES STATED THAT THE INS BATTERY WAS DEAD AND THEY HADN?T CHARGED THE INS. PATIENT SERVICES HAD THE PATIENT CONNECT THE RECHARGER TO THE CONTROLLER AND START AN INS CHARGING SESSION. THE PATIENT CONFIRMED SEEING RECHARGING WITH EXCELLENT RECHARGE QUALITY. PATIENT SERVICES REVIEWED THAT THE INS MUST BE CHARGED TO AT LEAST 30 PERCENT IN ORDER THE INS TO BE TURNED ON AND ACCESS MRI MODE. THE PATIENT WOULD CALL BACK ONCE THE INS WAS CHARGED ENOUGH TO BE WALKED THROUGH ACCESSING MRI MODE. THE EVENT OCCURRED IN (B)(6) 2020. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.