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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 Energy Output Problem (1431); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 04/15/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product type: lead. Product id: 977a2, serial#: unknown, explanted: (b)(6) 2021, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the patient had a surgical lead that was explanted due to an unsatisfactory result in pain treatment. The patient had better results beforehand with a percutaneous lead. The decision to try the surgical lead was a clinical one due to high differences in paresthesia threshold depending on body position. It was noted that the patient was alive with no injury.
 
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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 Key12310729
MDR Text Key266199062
Report Number3004209178-2021-12284
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 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/23/2020
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: 08/11/2021 Patient Sequence Number: 1
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