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

Model Number 309201

Device Problems Difficult to Insert (1316); Shipping Damage or Problem (1570); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report #3010291427-2020-00021 for report of other lead with same issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a basic evaluation trial patient who was using an external neurostimulator (ens) for unknown pelvic health indications.It was reported that the lead kinked and was unable to be straightened out.The kink in the bottom of the lead prevented it from being able to be inserted into the foramen needle.The physician tried to pull back on the lead to get the stylet to straighten out at the bottom of the lead, but were unable to remedy the issue intra-operatively, so a new lead was opened.The issue was resolved at the time of the report.There were no patient symptoms or further complications reported at this time.Additional information was received from a healthcare provider via a manufacturer representative (rep).The rep clarified that there were two leads that had the same issue (a kink in the bottom which prevented insertion into the foramen needle).The physician though these were out of box issues, but it was not known for sure.When asked if the cause of the kinked lead had been determined, they replied, "no," and when asked what most likely cause or contributed to the issue, they responded it was unknown, but a potential cause was the handling of the lead as the physician tried to insert it in the foramen needle.

Manufacturer Narrative

Product analysis #258436128: analysis information -- 2020-12-28 10:46:39 cst pli# 20 product id# 309201 below is unedited, system generated text based on the analysis finding code(s).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 the {x} electrode at the distal end of the lead was bent.Continuation of d10: product id neu_stylet_acc lot# unknown, product type: accessory.Product id: neu_stylet_acc, lot#: unknown, product type: accessory.Product id: 306001, lot#: 60242679, product type: screening device.See manufacturer report #3010291427-2020-00021 for report of other lead with same issue.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: 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: 10780477
• MDR Text Key: 230224057
• Report Number: 3010291427-2020-00022
• 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
• Report Date: 12/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: 309201
• Device Catalogue Number: 309201
• Device Lot Number: 60241721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR