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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 Failure to Interrogate (1332); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554); Insufficient Information (4580)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for spinal pain. Manufacturer representative (rep) reports he spoke to patient today. Patient indicated he has been having shocking sensation all over his body even when he bends down to pick up his cat. Caller reports the shocking sensation started about 1 week ago, but then patient mention yesterday after clarification was asked. Caller reports patient conference his wife and wife indicated the shocking sensation has been awhile, unknown if its stimulation vs shocking sensation. Wife indicated when patient goes to bed, the stimulation is strong and have to turn stimulation off at night. Caller reports patient have not been charging his device for a week and the controller unable to communicate with his implant.  caller reports patient had difficulty charging his implant for a month, ins protruding out and cannot get connection so patient had given up on charging. Caller reports stimulation is off and continues to feel shocking sensation all over his body. Caller reports indicated he fell wednesday night due to his left leg being numbed and feeling dead, caller do not known how patient landed or if he caught himself before he fell. Caller reports patient had an appointment with dr. (b)(6) but was cancelled, unknown reason why cancelled. Redirect caller to patient's hcp.
 
Manufacturer Narrative
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 Key12858091
MDR Text Key285453523
Report Number3004209178-2021-17465
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
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 Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/29/2020
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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