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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 Intermittent Continuity (1121); High impedance (1291); Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins). It was reported that the patient had mentioned to me during our reprogramming that it felt like her stimulation had been turning on and off on its own. She has had previous "cycling" programs so she was thinking it was that. After giving her some new groups that were not cycled she noticed it happening. Rep confirmed cycling was not activated. Rep ran an impedance check and only electrode 14 was "avoid" all others were "ok". The impedance ranges for 14 were ranging from 14 ,010 to 24,730. Rep was not using that contact in her new group. She also has a cervical system that we programmed first so she thought maybe it was due to a long programming session. She followed up with rep and confirmed that even at home after a couple of days she felt it turning on and off. Sometimes in relation with movement, other times not. Patient denies any falls. She did have a right hip replacement a few months ago.  the patient has a follow up with healthcare provider (hcp) on (b)(6) 2021 and will discuss further with rep. The issue is not resolved. No symptoms 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 Key11680364
MDR Text Key248557424
Report Number3004209178-2021-06178
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
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
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 Received05/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/21/2019
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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