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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Energy Output Problem (1431); Insufficient Information (3190)
Patient Problem Device Overstimulation of Tissue (1991)
Event Type  malfunction  
Event Description
It was reported that the patient felt a stronger than usual stimulus sensation while in a lying position. It was stated that although adaptive stim (as) was thought to be ¿on,¿ that it was found that as was off when the implantable neurostimulator (ins) was checked at the time of the event. The patient reportedly ¿had no awareness of operating the patient controller¿ on their own. The as feature was turned on and the patient¿s condition returned to its original state; the issue was considered resolved at the time of report. It was unknown whether any external factors may have led or contributed to the issue. The patient¿s physician¿s observation about causality was asked but unknown. There were no surgical interventions planned or performed and the spinal canal stenosis patient was alive with no injury at the time of report. No further complications were reported or anticipated.
 
Manufacturer Narrative
Report source country: (b)(6). If information is provided in the future, a supplemental report will be issued.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12968229
MDR Text Key281991754
Report Number3004209178-2021-18287
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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