MAUDE Adverse Event Report: MEDTRONIC, INC.; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97754
Medical Device Problem Codes	Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 37761 lot# serial# (b)(6) implanted: explanted: product type recharger section d information references the main component of the system.Other relevant device(s) are: product id: 37761, serial/lot #: (b)(6), ubd: , udi#: h3: analysis of the 37761 desktop charger (dtc) (serial number (b)(6)) revealed a bent connector pin.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 (pt) regarding an external device.The caller had a broken desktop charger (dtc) connector pin.About a month and a half ago when the pt attempted to charge their implanted device, they were only able to charge their implant if the dtc was plugged into the recharger.4 days ago the recharger went totally black and the pt was no longer able to use the recharger.Pt said their device was off in their body and it had been really bad.During call pt verified that the dtc connector pin was loose and was not straight, pt verified no damage to recharger.Pt mentioned that they had an eye problem over the call.Pt called again and reiterated details of case.Pt confirmed receiving the new desktop charger (dtc) but issue was not resolved by replacement dtc.The recharger (insr) was only charging the implant when plugged into the wall with the desktop charger (dtc).No symptoms were reported.
Additional Manufacturer Narrative
Regulatory report incorrectly sent on the recharger in 3004209178-2023-20766.This is the correct report.No further updates will be sent on the recharger.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
(b)(6) 2021 rtg0187016 x2 rpl 312895: pt called and reiterated details of case.Pt confirmed receiving the new desktop charger (dtc) but issue was not resolved by replacement dtc.The recharger (insr) was only charging the implant when plugged into the wall with the desktop charger (dtc).A replacement insr was sent out.No symptoms were reported.

• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18088170
• Report Number: 2182208-2023-03320
• Device Sequence Number: 12451164
• Product Code: LGW
• UDI-Device Identifier: 00643169763296
• UDI-Public: 00643169763296
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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 Model Number: 97754
• Device Catalogue Number: 97754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Age: 59 YR
• Patient Sex: Female