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

Model Number	399930
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 from a patient with an implantable neurostimulator (ins).The patient stated that their active lead is ¿running high¿ so they are having to re-adjust it to make it work.The patient stated that the issue started 3-4 years ago and is getting worse.Their lead is connected to a different manufacturer¿s ins.The patient was redirected to follow up with that manufacturer.The patient stated that the manufacture representative (rep) and healthcare professional (hcp) wanted to know the lead information to try and reprogram the device with the lead.Patient services reviewed that the available registration information can be faxed to a secure line and the rep/hcp can call directly.There were no patient symptoms reported and no complications reported.

• Brand Name: SPECIFY
• 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: 7386042
• Report Number: 6000153-2018-00005
• Device Sequence Number: 1095028
• Product Code: LGW
• UDI-Device Identifier: 00885074087351
• UDI-Public: 00885074087351
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018

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: 12/12/2009
• Device Model Number: 399930
• Device Catalogue Number: 399930
• Device Lot Number: V001702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1