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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins). The reason for call was pt stated that on (b)(6) 2020 they saw their dermatologist and was diagnosed with an infection. Pt mentioned that they believe that they had a staph infection 3-4 weeks before being diagnosed with an infection on (b)(6) 2020. Pt stated after they were diagnosed with an infection, "they started them on medication and tried to biopsy it and it was not getting better so they ended up taking it out". Pt the stated " it became more infected anyways and then they removed more of it". Pt stated "the battery is out and the paddle has been explanted but the leads are still in". The patient was redirected to their healthcare provider (hcp) to further address the issue.
 
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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 Key11517357
MDR Text Key240733464
Report Number3004209178-2021-04515
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/18/2019
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: 03/18/2021 Patient Sequence Number: 1
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