MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	978B128
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient had pain with increase in stimulation.The patient fell, the hcp tried troubleshooting.Lead revision was done, whole lead removed and new lead placed.The issue was resolved at time of report.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13994320
• Report Number: 2649622-2022-06280
• Device Sequence Number: 20106351
• Product Code: EZW
• UDI-Device Identifier: 00763000203726
• UDI-Public: 00763000203726
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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: 12/10/2022
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA2CB1M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/04/2022
• Date Device Manufactured: 02/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 93 KG