MAUDE Adverse Event Report: MPRI SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	977C290
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Stenosis (2263)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Information was received via a manufacturing representative (rep) regarding a patient who was implanted with a neurostimulator (ins).Information was reported that during a procedure as provider was trying to center lead in epidural canal patient lost neurological function on right side of body as reported by neuromonitoring representative.The surgeon and physician assistant immediately removed the lead and began to flush the area repeatedly.The patient gained full motion again, but provider decided to cancel the case and not proceed.The patient has a stent in his brain and other unknown issues.No further complications were reported.No additional patient symptoms were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received.The healthcare provider said the cause of the patient losing neurological function was likely related to mild cervical stenosis.No further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6841886
• Report Number: 2649622-2017-10154
• Device Sequence Number: 18962504
• Product Code: GZB
• UDI-Device Identifier: 00643169464667
• UDI-Public: 00643169464667
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: 977C290
• Device Catalogue Number: 977C290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 10/20/2017; 01/14/2019
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/24/2017; 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR