MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	7427
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare provider (hcp) reported that the patient (pt) had a history of a previous unsuccessful spinal cord stimulator that had been placed back in 2006, and was removed on an unknown date. the pt was reporting point tenderness under the site of the previous lead connectors/extenders position.A decision was made to remove the extensions on (b)(6) 2024.The lead was not removed due to the high risk for complication and no clinical indication. no symptoms were reported against the ins that had previously been implanted. no device issues reported against the extensions.
Additional Manufacturer Narrative
Continuation of d10: product id: 748940 ((b)(6)); product type: 0191-extension; implant date: (b)(6) 2004; explant date: (b)(6) 2024.Product id: 748940 ((b)(6)); product type: 0191-extension; implant date: (b)(6) 2004; explant date: (b)(6) 2024.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received on 2024-jul-22.The rep reviewed notes for this patient and did not see any appointments or notes listed other than the explant that took place on (b)(6) 2024.Patient device registration had attempted to confirm the ins explant date with the physician.The physician's office reported the ins was removed "years ago" and the extensions were not removed until (b)(6) 2024.They noted the lead was buried and inactivated (remains in the patient).The hcp was not able to provide any further information regarding any upcoming procedures for the pt.The ins explant date of "2006" could not be verified.No further information was provided.Additional information was received on 2024-aug-09.The hcp reported that the patient (pt)'s implant was disconnected years ago and was nonfunctional.They did not remove the implant and they do not have records pertaining to that surgery.The surgery done on (b)(6) 2024 was the removal of pt's spinal paddle lead connectors.
Additional Manufacturer Narrative
Continuation of d10: product id 748940.Serial# (b)(6).Implanted: (b)(6) 2004.Explanted: (b)(6) 2024.Product type extension.Correction: event description (b5) hadn't updated when previous reports were sent.B5 now includes all of the information.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SYNERGY
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19819859
• Report Number: 2182207-2024-03235
• Device Sequence Number: 19674745
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2005
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/03/2024
• Date Device Manufactured: 10/15/2003
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."; SEE H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female