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

Model Number NEU_ENS_STIMULATOR

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Malaise (2359); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977d260, serial# (b)(4), product type: screening device.Product id 977d260, serial# (b)(4), product type: screening device.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

Information was received about a patient implanted with an implantable neurostimulator (ins).It was reported that earlier this week the patient had surgery to remove a spine abscess.The patient had a trial scs on (b)(6) 2017.They came in for their lead pull on (b)(6) 2017.At that time the patient wanted to extend her trial a couple of days so that she could be certain.The patient's leads were redressed.It was noted that the patient does have psoriasis and there were areas of inflammation but none around the two leads.The patient came back for the lead pull on (b)(6) 2017 but the rep was not in attendance.The rep then called to follow up with the patient and they reported feeling ill with flu like symptoms.It was noted that members of her household had recently been ill.The rep tried to follow-up several times with the patient without success and just recently discovered that she had surgery to remove the abscess.

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 a manufacturer's representative (rep).The rep reported that the serial number on the leads was unknown.The cause of the spinal abscess is that it is a presumed as a result of an infection following an scs trial.

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.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6347900
• MDR Text Key: 67923882
• Report Number: 3007566237-2017-00749
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2017
• 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