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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEUROMODULATION DEVICE

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MEDTRONIC NEUROMODULATION NEUROMODULATION DEVICE Back to Search Results
Model Number NEU_UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 04/21/2021
Event Type  Death  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The family member reported via the manufacturer representative that the patient had a self-described bad back and weakness and was looking forward to the results of a spinal cord stimulation trial. The trial was unsuccessful and trial leads were explanted. An mri was done on (b)(6) 2021 and imaging indicated a possible brain and spine and systemic infection, of unknown origin or cause. The patient passed away on (b)(6) 2021. Further information received from a healthcare provider (hcp) reported that the patient presented to the emergency department and imaging of the cervical spine and brain showed localized abscesses in the cervical area and the brain. It was indicated that the abscesses were not near the leads of the manufacturers system. The hcp was not aware of the trial system procedure and no imaging had been done below the cervical spine. The hcp did not know where the infection may have started or if it was related to the trial system. The hcp also stated because she didn't know about the trial procedure she was not aware who the manufacturer of the trial system was. The patient had been transferred to comfort care after the brain abscesses were found and no further investigation, such as additional imaging, was performed.

 
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Brand NameNEUROMODULATION DEVICE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11867292
MDR Text Key252128591
Report Number2182207-2021-00874
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNEU_UNKNOWN
Device Catalogue NumberNEU_UNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 05/21/2021 Patient Sequence Number: 1
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