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

Model Number	977D260
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis determined that the lead was packaged incorrectly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The manufacturer representative reported that the healthcare provider (hcp) reported to them on (b)(6) 2020 during a procedure it was discovered that the trial lead kit came with 2 curved needles instead of one straight and one curved.They opened a new lead kit which had the correct needles in it, which resolved the issue for the hcp.No symptoms reported.The rep stated that the device was not used on the patient at all so the patient had no symptoms or issues.Additional information was received.It was noted the device would be returned.
Additional 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.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 10837094
• Report Number: 2649622-2020-22206
• Device Sequence Number: 17146791
• Product Code: LGW
• UDI-Device Identifier: 00763000006570
• UDI-Public: 00763000006570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 09/25/2024
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1