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

Model Number	306001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a trial lead.It was rep orted that pne lead, looking disformed at the distal end.The rep discussed that this can happen if the external part of the lead is pulled over the stylet. will replace the faulty leads, with backup to ensure that there is no risk of patients been cancelled.The issue was confirmed resolved.No symptoms reported.Additional information was received from a manufacturer representative (rep).The rep reported that the issue was discovered prior to use and the leads were never implanted.The cause was hard to tell, it could have been user error or if it was like this out of the pack.The customer just wanted to record that there were issues with this lot of pne leads, so that it could be looked at if other accounts had reported issues.The rep would be spending time with the hcp next week to look at any possible training requirements too.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): AVAILMED S.A.DE C.V.9; c.industrial lt.001 mz.105; tijuana,bc 22444 ; MX 22444
• Manufacturer (Section G): AVAILMED S.A.DE C.V.9; c.industrial lt.001 mz.105; tijuana,bc 22444 ; MX 22444
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13591938
• Report Number: 3010291427-2022-00008
• Device Sequence Number: 12217306
• Product Code: EZW
• UDI-Device Identifier: 00763000114077
• UDI-Public: 00763000114077
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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: 07/19/2023
• Device Model Number: 306001
• Device Catalogue Number: 306001
• Device Lot Number: 60308596
• 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: 02/11/2022
• Initial Report FDA Received Date: 02/24/2022
• Date Device Manufactured: 07/19/2021
• 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
• Patient Sex: Unknown