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

Model Number 3210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other application component are product id 3487a, serial# (b)(4), implanted: (b)(6) 1997, product type lead.Product id 3487a, serial# (b)(4), implanted: (b)(6) 1997, product type lead.

Event Description

Information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that patient had implant fist device and he used 9v batteries for it, it lasted 11 years.It went way past its shelf life and patient was in surgery to change out.Patient had the second device implanted, it lasted for 8 years and it had been running great.Additional information from patient was received.It was reported that patient¿s first implant had complication with infection where the infection was going up the lead wire toward his spinal cord.Patient had redo surgery for wound infection removal.Because patient had infection too closed to his spinal cord, so patient had doctor move the implant from the right side to left side and he never had problem with infection again, no complication after that.No further complication or event was reported.

• Brand Name: MATTRIX
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7149746
• MDR Text Key: 95896188
• Report Number: 3007566237-2017-05324
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3210
• Device Catalogue Number: 3210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention