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

Model Number	3777-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: product id: 97715, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer with an implantable neurostimulator (ins) for post lumbar laminectomy.It was reported that one of the leads was broken and needed to be replaced with a new one.The patient was waiting for her appointment to schedule the next procedure.No patient symptoms were reported.No further complications were reported/anticipated.

• 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: 8129691
• Report Number: 6000153-2018-00020
• Device Sequence Number: 296111
• Product Code: LGW
• UDI-Device Identifier: 00613994188632
• UDI-Public: 00613994188632
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2013
• 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: 11/30/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention