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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); Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97745, lot# serial# (b)(4). Product type programmer: patient product id: 97755, lot# serial# (b)(4). Product type: information references the main component of the system. 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 (pt) regarding an external device. Recharging antenna (rtm) nlf043616n and controller nld017097n. The reason for call was the patient received the message "cannot find device" (pss understood no device found). Patient stated that they attempted to go through passive recharge mode but they were unable to proceed past passive recharge mode after 55 minutes of trying. Over this past weekend, patient stated that they started to feel recharger (rtm) paddle and relay box get hot, patient verified that they received a burning mark from the rtm on their skin. An email was sent to the repair department to replace the rtm. Information was received from a patient (pt) regarding an external device. Nld017097n. The reason for call was over the past weekend the controller displayed two screens at one time (pt verified that nothing was plugged into the controller). Patient reset the controller and that caused the screen to become blank and unresponsive. Patient reset the controller again but the controller continued to be unresponsive. Patient stated that they were unable to charge their controller and since tuesday both the patient implant and controller are depleted. 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 Key11591104
MDR Text Key245928524
Report Number3004209178-2021-05182
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 06/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2018
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 Received06/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2017
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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