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U.S. Department of Health and Human Services

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

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MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
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.
 
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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 Key5428155
MDR Text Key38012625
Report Number2649622-2016-02636
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
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 Date12/15/2019
Device Model Number977D260
Device Catalogue Number977D260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/18/2016
Initial Date FDA Received02/10/2016
Date Device Manufactured12/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age00078 YR
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