FDA.reportPublic FDA data

MAUDE MDR 25341035

MDR report key
25341035
Report number
3006705815-2026-03426
Event key
0
Event type
3
Date of event
2026-03-03
Date received
2026-05-31
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
1
Health professional
1
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
SARA SPEYERER
Address
6901 PRESTON ROAD PLANO TX 75024 US
Phone
972-972-9723
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
244090OCTRODE LEAD KIT, 60CM LENGTHSCS LEADST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)LGW31863186A000160753NN
288074OCTRODE LEAD KIT, 60CM LENGTHSCS LEADST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)LGW31863186A000160753NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-05-310O

Event Narratives#

N

Patient 0

PATIENT WEIGHT AND DATE OF EVENT ARE ESTIMATED. THE EVENT OF UNCOMFORTABLE AND SHOCKING FEELING WAS REPORTED TO ABBOTT. SYSTEM REMOVAL WAS DECIDED DUE TO UNCOMFORTABLE STIMULATION AND SHOCKING SENSATION ISSUES. NO EXPLANT DATE AT THIS TIME. THE PATIENT DECLINED ANY PROGRAMMING AND REFUSED TO CHARGE CONTROLLER OR IPG. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

D

Patient 0

IT WAS REPORTED THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. PATIENT DECLINED TROUBLESHOOTING AND REQUESTED THE SYSTEM BE REMOVED. AS A RESULT, THE SYSTEM WAS EXPLANTED.