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

Model Number	3778-60
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The manufacturer representative reported that during a replacement surgery one of the leads would not reseat into the new battery port.Both ports were attempted before one port was plugged and the lead was left in the patient.The other lead was working fine with high impedances only on electrode 6.It was noted that 90% of the programming had been on the functioning lead prior to replacement so they were able to retain good coverage post-operatively.There were no known external or patient factors the contributed to the issue.When comparing the size and appearance of the leads one electrode on the lead that did not reseat appeared to be bent.The issue was not resolved at the time of the report.

• Brand Name: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 12526567
• Report Number: 6000153-2021-00052
• Device Sequence Number: 1113030
• Product Code: LGW
• UDI-Device Identifier: 00613994721945
• UDI-Public: 00613994721945
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 07/05/2015
• Device Model Number: 3778-60
• Device Catalogue Number: 3778-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 57