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

Model Number NEU_UNKNOWN_LEAD

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

Patient Problems Reaction (2414); Cognitive Changes (2551)

Event Date 06/28/2016

Event Type  Injury  

Event Description

The manufacturer's representative (rep) reported while in the process of doing a trial, the leads were put in, but the external neurostimulator (ens) hadn't been hooked up yet.After the leads were put in the consumer became incoherent and couldn't provide cognitive feedback.The doctor felt this had to do with a medication they may have taken or it was a reaction to lidocaine.Emergency medical services were called and the consumer was taken.The trial was temporarily aborted but the leads were in a good position so they were taped down and left in place.The rep.Was planning on seeing how the consumer was doing in a couple of days; if they were okay they would try to hook up the ens.

Manufacturer Narrative

(b)(4).

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 manufacturer's representative (rep) reported the physician was positive the trial was not the cause of the patient's incoherent response, but had a fluctuating blood pressure.The rep.Completed the trial the following day with success.

• Brand Name: UNKNOWN LEAD
• 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: 5805030
• MDR Text Key: 49891513
• Report Number: 3007566237-2016-02671
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• 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