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

Model Number	3777-45
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was unclear what specific lead had the issue.See manufacturer report #6000153-2016-00469.This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient reported a lead issue.The patient¿s spine was twisted to the right and there was an issue with the right lead.He needed another revision.He was being given full body electrical sonic pulses on each of his 3 leads before trying another surgery to revise.Relevant medical history included cervical radiculopathy.Follow-up was performed to determine what had led to the lead issue, if the lead issue was confirmed and what it was specifically, and what actions were taken to address the event.

• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 8722197
• Report Number: 6000153-2016-00470
• Device Sequence Number: 2004480
• Product Code: LGW
• UDI-Device Identifier: 00643169157545
• UDI-Public: 00643169157545
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: Health Professional
• Device Expiration Date: 09/10/2016
• Device Model Number: 3777-45
• Device Catalogue Number: 3777-45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2016
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1