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

Model Number 977D260

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

Patient Problem Loss of consciousness (2418)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient reported losing consciousness during implant of the trial leads.For the other lead, see manufacturer report #26496 22-2016-02628.

Event Description

The trial patient reported via the manufacturer representative (rep) that they had lost consciousness after the leads were placed while they were placing the dressing.The rep left the room and the patient then gained consciousness in the interim.During post procedural programming, the patient had trouble breathing and stated his chest hurt.He was then sent to the er where he received breathing treatments.It was not known what led to the event and if the issue was identified.The issue was not resolved at the time of the report.The rep was going to follow up with the patient during the trial to obtain further information.It was not known if any intervention took place or if there was patient injury.Additional information received from the rep in response to follow-up reported that the rep did not know the cause of the problem and no diagnostics had been performed.The difficulty breathing and chest pain subsided.No further follow-up was required.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5428155
• MDR Text Key: 38012625
• Report Number: 2649622-2016-02636
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2016

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 Expiration Date: 12/15/2019
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/10/2016
• Date Device Manufactured: 12/15/2015
• 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
• Patient Age: 00078 YR