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

Model Number	3487A-33
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Refer to regulatory report #6000153-2021-00045.The patient had two lead(s) and it was not clear which issues pertained to which lead.The referenced report pertains to the patient¿s other lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient had an abbott ins that was connected to their medtronic lead(s) and abbott rep told patient that there were 5 areas in leads that weren't working.Pt says during the implant surgery they found one lead wasn't working so they took one lead out and left one in.Pt says because of the "fixed piggyback" they used for the abbott battery, they had to move the ins "up to the middle of my back".Pt says "there is no give now because they had to connect it directly to the leads.  refer to (b)(4) for discomfort, and stimulation turned off, (b)(4) for ins dying.

• Brand Name: PISCES-QUAD
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 12327877
• Report Number: 6000153-2021-00046
• Device Sequence Number: 4136822
• Product Code: LGW
• UDI-Device Identifier: 00613994300461
• UDI-Public: 00613994300461
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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: 02/22/2012
• Device Model Number: 3487A-33
• Device Catalogue Number: 3487A-33
• Device Lot Number: V091227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/16/2021
• 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
• Patient Age: 51 YR