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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 Deliver Energy (1211); Failure to Interrogate (1332); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900)
Patient Problems Burn(s) (1757); Pain (1994); Discomfort (2330)
Event Date 02/18/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97745bp, serial#: unknown , product type accessory. Product id: 97745, serial#: (b)(4), product type: programmer patient. Product id: 97745, serial#: (b)(4), product type: programmer, patient. Product id: 97755, serial#: (b)(4), product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4). Analysis of the recharger (serial# (b)(4)) found the cable insulation was torn at the donut end, wires were cut and it was not able to find the ins. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that there was difficulty recharging. It was reported that the controller was 90% charged and the ins was at 70. It was reported the recharger would not connect. The patient had been trying to charge for hours and the no device found screen was seen. The patient reported seeing screen 16, 50, and the passive recharge screen with no numbers. The patient could not change recharging speed, and it was reported that the ins site was painful and tender. It was reported the recharger would get hot and the patient needed a new controller. Removing and replacing the battery did not resolve the issue and no cause was known. Additional information received stated that the issue was resolved and the initial issue occurred suddenly. It was reported the patient had no pain relief because the ins depleted and shut off. It was reported that the patient needed the device to live comfortable and the ins needs to be recharged daily. It was reported that by the time the replacement equipment arrived the patient was in extreme pain. It was reported the patient's back was painful and tender. The patient wanted a spare recharger (rtm), and it was reviewed that they would have to work with their hcp to get a spare. It was reported the rtm paddle got warm but did not burn. It was noted that the rtm wire had separated. There were no reported complications and no further complications were expected. Patient was implanted for spinal pain. Additional information was received from a friend/family member. The caller mentioned the first recharger antenna the patient had burned the patient's back because the recharger antenna was hot.
 
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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 Key12414366
MDR Text Key271286788
Report Number3004209178-2021-13288
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
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2018
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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