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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 Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Sleep Dysfunction (2517)
Event Date 05/01/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 3487a-33, lot#: j0309614v, implanted: (b)(6) 2003, explanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: 3487a-33, serial/lot#: (b)(4), ubd: 20-feb-2007, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a manufacturer representative (rep) and a consumer regarding a patient with an implantable neurostimulator (ins). It was reported that the patient was not getting pain relief since they had the new ins implanted, so the lead was replaced in (b)(6). The rep thought everything was fine post-op until about two weeks after when the patient still reported no relief. The rep met the patient for reprogramming on (b)(6) 2020 as they were getting sensation in the area of relief, felt stimulation, but they didn't have pain relief. The patient's husband said the ins didn't work well and they had to make changes to the settings because the patient couldn't sleep. The patient was able to get settings that allowed her to sleep, but the pain relief didn't match what she had with previous devices. The patient said her life has been very miserable since the old device/lead failed and she was disappointed with the new device. No further complications were reported.
 
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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 Key10101538
MDR Text Key196666104
Report Number3004209178-2020-09367
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,Followup,Followup
Report Date 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2020
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 Received05/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/17/2019
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: 05/29/2020 Patient Sequence Number: 1
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