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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 97716
Device Problems Break (1069); High impedance (1291); Application Program Problem (2880); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Type  malfunction  
Manufacturer Narrative
Information references the main component of the system. Other relevant device(s) are: product id: 09100-60, serial/lot #: unknown, ubd: , udi#: if information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative [rep], foreign) regarding a patient who was implanted wi th an implantable neurostimulator (ins) for unknown indications for use. It was reported that there was high impedance causing out of regulation (oor). The patient had very strong settings and possibly something wrong with lead number 1. Electrode 1 was broken and sometimes in warnings. The system also talked about electrodes 0, 1, and 2. A device data report and session report were provided with a request to investigate. It was noted that the oor was triggered by certain at specific body positions. Additional information was received from the rep. It was reported that the impedance used for therapy were all between 1220 and 1600 ohms. It was noted that the patient was not involved in any accident/sporty activity, but that the attacks the patient had could result in him making sudden movements. The patient also would twist his neck a lot to feel the paresthesia throughout his entire head. It was noted that this could be an influence for the open circuit. Additional information was received from the rep. It was reported that the rep first visited the patient on (b)(6) 2021, and later visited on (b)(6) 2021. The serial number of lead number 1 was unknown, and the implant date was in january of 2019. The patient experienced insufficient pain relief as a result of the oor and high impedance. Contact with the manufacturer's technical services was made along with an attempt at reprogramming. It was noted that this information was confirmed with the physician/account.
 
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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 Key11852823
MDR Text Key266979520
Report Number3004209178-2021-08005
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Model Number97716
Device Catalogue Number97716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/08/2020
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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