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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Break (1069); High impedance (1291); Impedance Problem (2950); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problem Discomfort (2330)
Event Date 01/07/2021
Event Type  Injury  
Manufacturer Narrative
Product id 977a260 lot# serial# (b)(4). Implanted: (b)(6) 2020 explanted: product type lead. Product id 977a260 lot# serial# (b)(4). Implanted: (b)(6) 2020 explanted: product type lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: (b)(6) 2023, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: (b)(6) 2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins). The reason for call was rep initially reported  electrodes 0, 3, 5 are out and 0-6 show maybe open or short. Rep then said impedance is greater than 40k ohms for every electrode. Technical services(ts) reviewed with rep that patient probably has a break in the lead or the lead pull enough for the electrodes to not make contact in the header block of the neurostimulator. Reviewed with rep that surgical intervention is needed to address this issue. Patient reported lifting heavy fire wood and lots of twisting motion early in the year. Troubleshooting was not required. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue. Pt called in and stated that he was with the rep at hcp office today and the rep determined that the leads have gotten damaged. Rep programmed pt around the damaged lead. Pt got home and tried to change to group b to stop his foot from aching and the controller showed an error message: device not ready. Cannot continue call your dr 82. Pt stated he called the rep about the message and the rep told pt to call pats and request to have the controller replaced. Pss looked up the error message and reviewed with pt the meaning: the neurostimulator stimulation settings are not complete. Pss is sending an fyi message to the local field reps about pt call and the meaning of the error message.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12139376
MDR Text Key261615195
Report Number3004209178-2021-10561
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
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 Received07/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/07/2020
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: 07/08/2021 Patient Sequence Number: 1
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