MAUDE Adverse Event Report: MPRI PISCES-QUAD; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	3888-45
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Human-Device Interface Problem (2949); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
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 the manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that the physician went to implant lead and electrode was protruding and stylet was not holding in place.It was a new lead straight out of the box.Lead to be sent back for analysis.New lead was used.Issue resolved at this time.No further complications reported/anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow up report will be sent once analysis is complete.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the lead (lot# 3888-45) identified that the butt joint of the outer insulation was separated at the proximal end of the lead.This was determined to be use error.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A correction was made to reflect most accurate evaluation code- conclusion.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PISCES-QUAD
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7978888
• Report Number: 2649622-2018-17027
• Device Sequence Number: 16509921
• Product Code: LGW
• UDI-Device Identifier: 00643169887909
• UDI-Public: 00643169887909
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/29/2020

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: 06/25/2022
• Device Model Number: 3888-45
• Device Catalogue Number: 3888-45
• Device Lot Number: VA1SKNN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 11/08/2018; 01/22/2019; 09/29/2020
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 10/31/2018; 11/09/2018; 01/22/2019; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR