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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 Pocket Stimulation (1463); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 7495-51 lot# serial# (b)(4) implanted: (b)(6) 2002 explanted: product type extension product id 3487a-33 lot# j0114096v serial# implanted: (b)(6) 2002 explanted: product type lead product id 3777-45 lot# serial# (b)(4) implanted: (b)(6 2010 explanted: product type lead product id 3708160 lot# serial# (b)(4) implanted: (b)(6) 2010 explanted: product type extension. Information references the main component of the system. Other relevant device(s) are: product id: 7495-51, serial/lot #: (b)(4), ubd: 14-sep-2005, udi#: (b)(4) ; product id: 3487a-33, serial/lot #: j0114096v, ubd: 01-aug-2005, udi#: (b)(4). ; product id: 3777-45, serial/lot #: (b)(6), ubd: 14-dec-2013, udi#: (b)(4); product id: 3708160, serial/lot #: (b)(4), ubd: 21-dec-2013, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient reported that around (b)(6) 2021, the patient believed their "wire" got bumped and not too long after that they started feeling stimulation at the implanted neurostimulator (ins) site when the ins is turned on.   they explained that they normally felt stimulation in their legs and feet, but never recalled feeling stimulation at the ins site.   then, in (b)(6) 2021, they started having a "problem with the device", so their doctor took x-rays.   the patient was still waiting for the results of those x-rays.    patient services redirected the patient to their doctor to further address this 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 Key11866420
MDR Text Key267315454
Report Number3004209178-2021-08148
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
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2021
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 Received05/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/17/2019
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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