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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 Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Charging Problem (2892); Patient Device Interaction Problem (4001)
Patient Problem Electric Shock (2554)
Event Date 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant products: product id: 97745, serial#: (b)(4), product type: programmer, patient. 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. :controller (b)(4). The reason for call was patient reported controller was frozen on a bunch of different layered screens and therefore they couldn't use controller to adjust stimulation. Patient said they had wanted to adjust stimulation because they experienced a new change in stimulation sensation saying that whenever they would talk, moved or coughed they would feel static or a little jolt or zap that bothered them. Patient said that they hadn't felt the little jolts or zaps from the stimulator until the controller froze up. Patient said since the controller screen was frozen it was very difficult to get implant battery charged and it took hours to charge implant. Patient had not reset controller yet so pss walked patient through taking battery pack out and putting it back in. No damage was seen to controller or battery pack contacts. Reset resolved frozen controller issue, patient said they had been on group b but saw group a, patient was able to change to group b and said they had relief from pain but still had issues with the stimulation giving them little zaps. Patient was able to start charging at excellent. Frozen controller issue was resolved however patient said that stimulation jolting them hadn't resolved so pss had redirected patient to hcp to check device.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11921193
MDR Text Key253770234
Report Number3004209178-2021-08661
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2021
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/12/2021
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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