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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 Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 08/01/2020
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: 12-sep-2022, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 12-sep-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported the patient's leads poked out a little bit where they went into their spine. When they turned on low frequency and needed the buzz sensation, they could only keep it on for 15-20 minutes because of where the leads went in popped out a little bit. The patient could push it in, however there was a lot of pain in that area. The pain on low frequency started 4 months ago, prior to (b)(6) 2021. The patient noted their device was placed 2 years ago and they were now having issues with their legs, not pain but more like nervous legs. The patient could not sleep because of that issue. The patient mentioned that on high frequency their legs would constantly jerk but they would not feel stim. The patient could only have high or low frequency on for 15-20 minutes and their spine would hurt where the leads were if it was on for 15 minutes. The patient was redirected to their healthcare provider to further address the issue.
 
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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 Key11734165
MDR Text Key247685499
Report Number3004209178-2021-06783
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2020
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 Received05/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/20/2019
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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