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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); Failure to Deliver Energy (1211); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 04/25/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: (b)(4), serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead. Product id: (b)(4), serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: (b)(4), serial/lot #: (b)(4), ubd: 31-mar-2022, udi#: (b)(4); product id: (b)(4), serial/lot #: (b)(4), ubd: 31-mar-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was reported that the patient said that she can't increase or decrease her stimulation, and said that she can barely feel it, it's just a slight pulse on their right side and nothing on their left side. It's usually strong, but the patient can barely feel it now. The patient said that this started just today, but they were getting really big zaps like three days before this. The patient said she has had no falls or trauma and no exposure to emi. The patient was helped with the use of their controller and it shows stimulation is on, and she is on program a, but she doesn't have any other available programs. When she presses increase on setting one it says cannot provide desired settings. When she pressed the decrease button it she was at 3. 8v. No additional patient symptoms were reported. Additional information was received from the patient. The patient reported that she was still not feeling stimulation and there was no green light around the letter and she reset the controller twice. The patient tried to increase stimulation and she was getting settings not available. The patient reported that the ins was at 60% and the controller was 100% charged and she was on group a. The patient reported that after resetting the controller, there was green around group a. Additional information received from the consumer reported that the cause of the issue was the leads had been disconnected. The patient had surgery on (b)(6) 2020 to revise the issue and now it was resolved and everything was working.

 
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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 Key10457462
MDR Text Key212360895
Report Number3004209178-2020-14820
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
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 Received08/24/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/12/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/26/2020 Patient Sequence Number: 1
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