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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190); Audible Prompt/Feedback Problem (4020)
Patient Problems Burn(s) (1757); Erythema (1840)
Event Date 01/01/2021
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), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins). It was reported that the recharger (rtm) relay box and the cord going into the paddle was getting hot and shorting out. Patient (pt) stated that the rtm was burning their skin and causing a little bit of redness. Patient noted the relay box was also making a clicking noise. Pt states it takes a half hour for the rtm to connect with the ins before they begins to charge. Pt stated that it takes 30% of the charge from the controller, but only charges the ins 10%. Pt reports that because the rtm is getting hot, they were seeing errors. Pt has already taken the battery out to do a controller reset. Pt expressed that they're having a hard time charging due to these issues, and was concerned about using the cord until they get rtm replacement. Pt stated the relay box started getting hot a month or so ago, and the cord part was getting hot the last two or three nights.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11369870
MDR Text Key244317176
Report Number3004209178-2021-03118
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 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
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 Received05/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/29/2018
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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