MAUDE Adverse Event Report: AVAILMED S.A.DE C.V.9 INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 309201

Device Problems Shipping Damage or Problem (1570); Material Twisted/Bent (2981); Insufficient Information (3190)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an unknown source regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that during placement  they found lead included in kit was opened.It was noticed that the distal end of lead was flaccid.  medical doctor  attempted to advance stylet into lead further, but end of lead still flaccid.Physician then stated he did not wish to use this lead for procedure as he felt it was defective.They then use another 306001 from their back up supply. no symptoms reported.No further complications were reported/anticipated at this time.

Manufacturer Narrative

H3: device received, analysis not yet complete.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

Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the defective lead was not determined, but it was possibly the stylet not being advanced far enough and the site line being occluded by the blue silicone.

Manufacturer Narrative

Continuation of d10: product id neu_stylet_acc lot# unknown product type accessory h3: analysis of the lead (lot number 60253737) found the body of the lead was stretched.Analysis found this to be due to the procedure/use of the product.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.

Manufacturer Narrative

B5: corrected h3 (corrected): analysis identified that the electrode at the distal end of the lead (lot # 60253737) was perforated by the stylet.H6: only a26 is applied as an fdd in this event.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.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 a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient undergoing a trial lead placement procedure.It was noted that they opened the kit and proceeded with the procedure.When appropriate placement was found, the lead included in the kit was opened.It was noticed that the distal end of the lead was flaccid.The hcp attempted to advance the stylet into the lead further, but the end of the lead was still flaccid, even with stylet advanced completely.The hcp then stated that they did not wish to use this lead for the procedure, as they felt it was defective.Another lead was opened form their back up supply.Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the defective lead was not determined, but it was possibly the stylet not being advanced far enough and the site line being occluded by the blue silicone.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): AVAILMED S.A.DE C.V.9; c.industrial lt.001 mz.105; tijuana,bc 22444 ; MX 22444
• MDR Report Key: 11178350
• MDR Text Key: 240408082
• Report Number: 3010291427-2021-00002
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000114114
• UDI-Public: 00763000114114
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Model Number: 309201
• Device Catalogue Number: 309201
• Device Lot Number: 60253737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/15/2021; 04/20/2021; 04/22/2021
• Supplement Dates FDA Received: 02/02/2021; 04/21/2021; 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR