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

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.

• Brand Name: SPINAL-CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 10983435
• MDR Text Key: 220971321
• Report Number: MW5098300
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• 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 Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR