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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 Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. Product id: 97745, serial#: unknown, product type: programmer, patient. 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 and a healthcare provider who was implanted with an implantable neurostimulator (ins). It was reported that the patient had come in before an mri and their controller wouldn't hold a charge. The controller was charged over night, but when they went to use it , told them that it was too low to put the ins into mri mode. They did not have the charger with them so they couldn't plug it in. The patient wasn't using their system due to this. The patient further reported that one of the edges on the recharger paddle burned their skin when trying to charge. The recharger just got warm before. When they placed the recharger over the implant they got a screen saying to reposition the device. They had been trying to get an mri for 2 weeks, but they weren't able to because they needed to have the implant charged up and they couldn't charge it. They had charged the controller with the ac power cord and the controller was at 100%. They looked for damage on the recharger and they confirmed there wasn't damage. They tried to connect wirelessly to the implant and they saw battery empty, cannot provide stimulation, recharge implanted device. They reset the controller and it didn't resolve the issue. About a year prior they couldn't turn on or do something right with the controller, but they couldn't remember the details of the event. They reset the controller by taking the battery out and putting it back in which resolved the issue at the time.
 
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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 Key11860377
MDR Text Key266244240
Report Number3004209178-2021-08078
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,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
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 Received08/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2019
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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