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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION SPINAL-CORD STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Pain (1994); Swelling (2091)
Event Date 10/12/2020
Event Type  Injury  
Event Description

Patient called to report an adverse event involving her medtronic spinal-cord stimulator. Patient stated that she had a battery replacement surgery in (b)(6) 2017, and after the surgery she complained of pain at the site. Patient stated that for 3 years she was told by multiple doctors that it was nothing and then she was "narcotic seeking". Patient said during those 3 years she had intense pain and swelling. Patient stated she finally had the device explanted on (b)(6) 2020, and it was discovered she had a staph infection. Patient stated she is very concerned and wanted to help others by reporting that she walked around for 3 years with a staph infection.

 
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Brand NameSPINAL-CORD STIMULATOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key10983435
MDR Text Key220971321
Report NumberMW5098300
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/09/2020 Patient Sequence Number: 1
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