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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 977d260, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a trial patient via a manufacturer representative (rep).It was reported that the patient reported bleeding that was new and they went to the emergency room (er) for her assessment of new blood with trial leads.The patient also reported that she had some new pain.There were no contributing factors identified and there were diagnostics tests performed.It was possible that the lead would be pulled on (b)(6) 2019.The issue was not resolved at the time of the report and surgical intervention was not planned.There were no further complications reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id 977d260, serial# unknown, implanted: (b)(6) 2019 product type screening device.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that the rep was notified that the patient developed a post-trial infection.The patient was going to delay implant until the infection was cleared up.The patient was on antibiotics.No further complications were reported.

Event Description

Additional information received from a manufacturer representative (rep) reported that the patient was released and had a successful trial.The rep did not attend the lead pull, so no additional information was provided.There were no further complications reported or anticipated.

Manufacturer Narrative

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
• MDR Report Key: 8375185
• MDR Text Key: 137299793
• Report Number: 3007566237-2019-00484
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention