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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 Migration or Expulsion of Device (1395); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Communication or Transmission Problem (2896)
Patient Problems Device Overstimulation of Tissue (1991); Electric Shock (2554)
Event Date 03/02/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot#: (b)(4), ubd: 28-jan-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on (b)(6) noticed that her battery was taking 4 hours to charge, stated that it keep "losing connection, wheel would spin, would take forever to connect". Got so annoyed with it she decided to just not use the stimulator. Then november 1 she charged it and turned it on and it gave her "jolts" so she turned it back off. Also hcp took an x-ray and one of the leads migrated from bottom of t8 to bottom of t9 but still midline. No environmental factors noted. Md stated that she should have contacted him or manufacturer and not waited so long. Patient did not have charger along. Patient charged battery at home and was able to turn it on. Stim was strong at previous settings. Patient turned down amplitudes and stim felt better. Pt will try program and see how charging goes. Will call for appointment f issues with charger or if stim isn't helping. Prior to issue patient stated stim really helped her pain and was happy with relief. The issue was not resolved.
 
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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 Key11095508
MDR Text Key224581610
Report Number3004209178-2020-22765
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 company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 12/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2020
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 Received12/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/24/2019
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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