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

Model Number 3272-25

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Skin Inflammation (2443)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3440, lot# unknown, product type: accessory.

Event Description

A consumer reported the patient programmer (pp) antenna cord was frayed so it wouldn't allow the transmitter to connect to the implantable neurostimulator (ins).It was further reported that after the cord was frayed and the pp was used with the antenna the consumer would get an increase in stimulation.There were no traumas or falls reported.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the consumer reported when the new antenna was connected to the stimulator there was no surge anymore, so the increase in stimulation was resolved.According to the consumer when the wires were showing on the old antenna ¿there must have been an arc which caused surging in the stimulator, since it hadn¿t happened since the new antenna was used.¿ however, the consumer later reported they made an appointment with the healthcare provider (hcp) who said they couldn¿t fix the issue so they needed to have the manufacturer¿s representative (rep) come out and check their device.It was further noted the last time the consumer used their device after their appointment with their hcp on (b)(6) 2016 they woke up the following morning and noticed they had blisters on their toes; the consumer didn¿t know if the stimulator caused the blisters.On november 22, 2016 the rep.Reported the consumer had a sudden loss of efficacy the year prior that wasn¿t related to any specific event where they sometimes felt sometimes and sometimes didn¿t, and were even able to go to channel two and turn stimulation up all the way without any sensation.During the call a self-check was done on the transmitter and no code was present.It was noted the consumer had their antenna replaced previously but it didn¿t resolve the issue and they were only able to connect sometimes.

Manufacturer Narrative

References the main component of the system and other applicable components are: product id: 3210, serial# (b)(4), implanted: (b)(6) 2004, product type: transmitter.Product id: 3440, product type: accessory.

Event Description

Additional information was received from a manufacturer representative on (b)(6) 2016 reporting that technical services walked the manufacturer representative through what to do in order to turn off and then how establish communication.There were no error messages seen.The patient was going to have a complete system replacement with a health care professional (hcp).A referral was in progress for that replacement surgery with the hcp.The cause of the inability to communicate was due to the device being a matrix.The patient could turn up the system themselves to maximum amplitude with no parasthesia.It was reported that the patient typically ran their settings at 4v.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported the patient had replacement of the stimulator to resolve the blisters on her toes.

Manufacturer Narrative

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

• 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: 5953057
• MDR Text Key: 54892008
• Report Number: 3007566237-2016-03272
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2008
• Device Model Number: 3272-25
• Device Catalogue Number: 3272-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 04/04/2017
• Supplement Dates FDA Received: 11/28/2016; 11/30/2016; 04/24/2017; 09/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR