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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 Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554); Paresthesia (4421)
Event Date 08/19/2021
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 (pt) regarding an implantable neurostimulator (ins). The reason for call was to address a therapy related issue. Pt reported that on thursday, they had the ins turned on for the first time. Pt stated that on friday, they had to turn the ins off because if they cough hard, they feel a "zap" from the therapy going down their leg. Pt reported as well that if they are flat on their back, they feel a tingle that is "really painful". Pss asked, and the pt confirmed that these issues started on thursday, and the pt noted that if they shifted a little bit, the issue went away on thursday. Pt stated that the issue came back on friday, where the pt really noticed the zap and had to turn the ins off with the controller. Pt noted the ins does help them w/ their baseline pain, but stated they can't keep the ins on because of these new problems of zappingand uncomfortable tingle from t he therapy. Pt stated they tried turning the ins on saturday, but had to turn it off again because of these issues. Pt also reported that the implant site for the battery is irritated, but stated this could possibly be from healing from the surgery. Pt reported they feel a lot of pain from the "zaps". Pt noted that the manufacturing representative (rep) told the pt to contact them if they had any problems. Reviewed therapy expectations and offered to forward a message to the field.

 
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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 Key12373978
MDR Text Key268359897
Report Number3004209178-2021-12980
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received08/26/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/22/2021
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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