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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC EUROPE SARL PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erythema (1840); Fever (1858); Pain (1994)
Event Date 11/02/2020
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: 37081-60, serial/lot #: (b)(4), ubd: 06-mar-2019, udi#: (b)(4) ; product id: 37081-60, serial/lot #: (b)(4), ubd: 06-mar-2019, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (healthcare provider, foreign, clinical study) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that there was redness, pain, and fever in the surgical site (the right buttock) caused by a bacterial infection. Surgical observation on 08-dec-2020 found staphylococcus aureus. The ins and extension were explanted and not replaced on (b)(6) 2020.  laboratory testing on (b)(6) 2020 revealed no inflammatory syndrome.  the event resulted in in-patient hospitalization, an emergency room visit, an urgent care visit, and an unscheduled clinic or office visit. Etiology was related to the device or therapy, and related to the implant procedure. The device diagnosis was not applicable and the clinical diagnosis was a staphylococcus aureus infection. The event was ongoing. It was noted that the patient was 60 years old and weighed 105 kilograms at the time of consent.
 
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Brand NamePRIMEADVANCED
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11202536
MDR Text Key227794170
Report Number9614453-2021-00246
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2016
Device Model Number37702
Device Catalogue Number37702
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 Received04/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/04/2015
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: 01/20/2021 Patient Sequence Number: 1
Treatment
"SEE H10...."
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