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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Material Frayed (1262); Failure to Interrogate (1332); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Communication or Transmission Problem (2896); Connection Problem (2900)
Patient Problems Burn(s) (1757); Electric Shock (2554)
Event Date 04/29/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, serial# (b)(4). Product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) regarding an external device. The reason for call was about 6 months ago when recharging the pt would feel zapping and they noticed the plastic cord on the recharger was loose. Then over the weekend the equipment zapped them good and the recharger got very hot; the rtm relay box got hot. Pt noticed that it had been harder to connect and longer to charge their implant. Pt noted the recharger was not connecting to their back steadily and the cord was getting hot and looked frayed a bit. Pt noticed it was also zapping them. Pt noted they had to hold the equipment straight up, and if not they would loose connection while recharging the implant. The patient was struggling to keep their stimulator charged. The recharging cord was getting very hot to the touch, not connecting steadily and the patient thought that it was slightly burning their back. The recharger was replaced to resolve the issues.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13046356
MDR Text Key287828584
Report Number2182207-2021-02209
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2019
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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