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

Model Number NEU_ENS_STIMULATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bruise/Contusion (1754); Discomfort (2330); Loss of consciousness (2418); Electric Shock (2554)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 977d260, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016, product type: screening device.Product id: 977d260, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2016,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 from a manufacturer representative regarding a trial patient.It was reported that the patient had bumped up against a fence or guardrail and was shocked, knocked unconscious for several minutes, and hit their head and arm.It was noted that the patients arm was bruised and sore.The manufacturer representative explained that the actions taken to resolve the issue were that the trial leads were pulled.

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
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6068284
• MDR Text Key: 58813871
• Report Number: 3007566237-2016-03833
• 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
• Report Date: 10/31/2016

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?: 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
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: 10/04/2016
• Supplement Dates FDA Received: 09/26/2017
• 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): Other