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

Model Number	978A128
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 97810, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
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's recharging time was lengthy so a pocket revision was scheduled.The patient complained in pre-op for the pocket revision that their symptom improvement hadn't been greater than 50% and the stimulation they did feel was in their leg.The patient denies any falls or any trauma that would have affected the pocket or the lead.During the pocket revision procedure, they tested the existing lead, and motor response was no bellows with strong toe.Image on fluoroscopy showed the depth of the tined lead being too deep and all electrodes were located past the anterior portion of the sacrum.The tines were straddled between the sacrum.One tine was below the anterior portion of the sacrum and the other was slightly above the sacrum.The lead was replaced and had bellow and toe motor response and was placed at appropriate depth.The battery was repositioned to be parallel to the skin in order for the battery to pair with the recharger.
Additional Manufacturer Narrative
Continuation of d10: product id 97810, serial# (b)(6) implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: implantable neurostimulator, two reports were inadvertently submitted, and all future information will be submitted under (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient's recharging time was lengthy so a pocket revision was scheduled.The patient complained in pre-op for the pocket revision that their symptom improvement hadn¿t been greater than 50% and the stimulation they did feel was in their leg.The patient denies any falls or any trauma that would have affected the pocket or the lead.During the pocket revision procedure, they tested the existing lead, and motor response was no bellows with strong toe.Image on fluoroscopy showed the depth of the tined lead being too deep and all electrodes were located past the anterior portion of the sacrum.The tines were straddled between the sacrum.One tine was below the anterior portion of the sacrum and the other was slightly above thesacrum.The lead was replaced and had bellow and toe motor response and was placed at appropriate depth.The battery was repositioned to be parallel to the skin in order for the battery to pair with the recharger.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 13335155
• Report Number: 2649622-2022-01644
• Device Sequence Number: 4886006
• Product Code: EZW
• UDI-Device Identifier: 00763000203603
• UDI-Public: 00763000203603
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 978A128
• Device Catalogue Number: 978A128
• Device Lot Number: VA2BNPS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 01/31/2022
• Date Device Manufactured: 01/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Female