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

Model Number 978B128

Device Problems Break (1069); Malposition of Device (2616); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

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 Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that when implanting the new lead 978b128, the surgeon noticed the patient's anatomy did not help in the placement of the lead correctly.The surgeon attempted to insert the lead 3 or 4 times without successful motor responses from the patient, all confirmed with x-ray.On one of the attempts, the surgeon noticed some resistance when implanted.When x-ray was obtained, it was noticed one of the electrodes did not seem to be in the correct spot.When the surgeon removed the lead, a break was noticed on the lead between electrodes 3 and 2. a new lead was picked by the circulating or nurse and implanted correctly without issues.The patient will be followed up as normal by the surgeon.The scrub nurse discarded the broken lead in the sharps container as there was the possibility of sharp edges at the break.This occurred prior to field contact being able to ask them to return the product or obtaining pictures of the broken product.Field contact informed nurses, the product should be returned in the event this happens in the future.

• Brand Name: SURESCAN
• Type of Device: 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: 16964424
• MDR Text Key: 315642513
• Report Number: 2649622-2023-12776
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA2RM09
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2023
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention