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

Model Number	3778-60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that two electrodes broke off of the lead.There were no environmental, external, or patient factors that may have led, or contributed to the issue.The patient went into surgery for a normal eos of battery.The patient and physician wanted to replace the entire system to be mri compatible.While removing the old lead two electrodes broke off in the battery pocket while pulling out through the pocket.An x-ray was taken to confirm where the electrodes were.They were determined to be in the pocket where there battery sat, and the physician was able to retrieve them.The issue was resolved.No symptoms were reported.
Additional Manufacturer Narrative
Continuation of d11: product id 3778-60 lot# serial# (b)(6).Lead product id 37714.Serial# (b)(6).Implantable neurostimulator correction: no further reports will be sent under this regulatory report #6000153-2020-00021 please refer to regulatory report #3004 209178-2020-19119 for all future reporting.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.
Additional Manufacturer Narrative
Product analysis #704007347: analysis information -- 2021-03-05 10:19:01 cst pli# 10 product id# 3778-60 h3.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the #3 and #6 conductors were broken in the distal end of the lead.Continuation of d10: product id 3778-60 lot# serial# (b)(6), product type lead h3.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the 1 and 2 conductor(s) was/were broken in the distal end of the lead.H6.Evaluation result code 3233 does not apply.Evaluation method code 4118 does not apply.Evaluation conclusion code 11 does not apply.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: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 10670497
• Report Number: 6000153-2020-00021
• Device Sequence Number: 11414528
• Product Code: LGW
• UDI-Device Identifier: 00613994721945
• UDI-Public: 00613994721945
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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: 03/26/2016
• Device Model Number: 3778-60
• Device Catalogue Number: 3778-60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 10/09/2020; 03/05/2021
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/02/2020; 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR