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

Model Number	305901
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
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 by a manufacture representative (rep) who confirmed the information with the healthcare provider (hcp) regarding a lead as nurse practitioner (np) was removing the foramen needle, the lead became caught in foramen needle which caused the lead to stretch and pull.The cause of the issue was not determined.The action/intervention taken to resolve the issue was a new lead was opened and used.The lead was discarded in between procedures before the rep could remove it from the account.No patient symptoms were reported and no further complications have been reported as a result of this event.

• Brand Name: INTERSTIM
• Common Device Name: 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: 9075024
• Report Number: 3010291427-2019-00006
• Device Sequence Number: 11555762
• Product Code: EZW
• UDI-Device Identifier: 00643169721166
• UDI-Public: 00643169721166
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: No Information
• Device Expiration Date: 04/26/2021
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 60191271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1