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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 Disconnection (1171); High impedance (1291); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  Malfunction  
Manufacturer Narrative

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) for non-malignant pain on (b)(6) 2019. It was reported that the patient saw a settings not available message on the controller. The patient said she keeps the battery charged up. The patient was told to reduce the intensity down to zero and then increase intensity. The patient said she would call the rep. The issue started about a month prior to the report. No symptoms or further complications were reported. Additional information was reported on (b)(6) 2020 that the patient tried increasing her intensity and got the settings not available screen, which is something she's seen before and was told it wasn't an issue. The patient mentioned that she first saw the settings not available message screen 6 months ago or longer. The patient said she pressed ok at the bottom of the screen and it shows her battery levels, but when she selects program 1 and tries to increase intensity, it gives her the settings not available screen. No further information was reported additional information was received from the patient on (b)(6) 2020. It was reported that the cause of the settings not available message was unknown. The device was reset, which resolved the message. No further complications were reported or anticipated. Additional information was received from a manufacturer representative and a consumer regarding the patient on (b)(6) 2020. It was reported that the patient had been seeing a settings unavailable message on her patient controller. The manufacturer representative ran a connectivity and impedance check on (b)(6) 2020 which found that lead 0-7 had no connectivity and high impedances on contacts 0, 3, 4, 5, 6, and 7. There was an allegation that the lead was disconnected. There were no external or environmental factors noted to be related to the issue. The manufacturer representative changed the patient¿s programming only to use contacts 1 and 2 on the other lead. It was noted that the issue was not resolved at the time of the report; however, the health care professional has no further information regarding the event. No surgical intervention has occurred or is planned.

 
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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 Key10474150
MDR Text Key205100322
Report Number3004209178-2020-15070
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/14/2019
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 Received08/27/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/23/2018
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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