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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); Charging Problem (2892); Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 03/10/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant 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 consumer regarding a patient with an implantable neurostimulator (ins). Information was received from a patient (pt) regarding an external device, recharger (rtm) with serial number (b)(4). The patient reported that for the last 2 weeks they had been having problems with the recharger. Patient spoke with rep who told them to call pats for a new recharger (rtm). When patient was having trouble connecting, the controller kept saying to move around the rtm and the patient was unable to charge. Patient reported that when they are finally able to get the rtm connected, it over heated and burned their skin (left a red mark). They reported that where the wire goes into the paddle is where it got hot and burned them. Patient said the cord was almost to the point where they couldn't touch it. Patient said they laid the rtm on the table and the whole thing was scalding hot and the controller battery had gone completely dead within a few minutes. Patient inspected the rtm and did not notice any physical damage. The issue was not resolved. An email was sent to the repair department to replace the 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 Key11569149
MDR Text Key242260923
Report Number3004209178-2021-04924
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 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2020
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 Received06/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2019
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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