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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 Electromagnetic Interference (1194); Overheating of Device (1437); Malposition of Device (2616)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 09/01/2021
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 healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an im plantable neurostimulator (ins). It was reported that the patient had three diathermy sessions on august 18th, 25th, and september 1st. They had forgotten that diathermy is a contraindication and had not turned off the ins. The patient stated they felt heat and pain at the device site. The rep performed an impedance test and everything was normal. Impedance control, connectivity, and charging were all ok. The issue was not resolved at the time of the report. No patient complications were reported as a result of this event.
 
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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 Key12469309
MDR Text Key271328403
Report Number3004209178-2021-13810
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2020
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/03/2019
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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