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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); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Burning Sensation (2146); Electric Shock (2554)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 977a260, serial/lot #: va2d7xe005, ubd: 18-mar-2025, udi#: (b)(4) ; product id: 977a260, serial/lot #: va2cwyv015, ubd: 03-mar-2025, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins). It was reported that the patient states that she was experiencing shocking, burning sensations at the lead incision and ins incision sites when the stimulation is on. Says she does not experience this when stimulation is off. The manufacturer representative (rep) will meet with the patient on 07/01 to evaluate the system.
 
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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 Key12093503
MDR Text Key264502531
Report Number3004209178-2021-10183
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
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 07/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received07/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/14/2021
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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