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

Model Number	3888-56
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
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 a manufacturer's representative (rep) regarding an implantable device.It was reported that the lead separated as the boot was being slid up over the extension.The issue was visibly apparent.The lead was replaced with a new lead.No further complications were reported or anticipated.No symptoms were reported.
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 ((b)(4)) found that the stim lead body out insulation separated at the butt joint on the proximal end.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, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7549302
• Report Number: 2649622-2018-08904
• Device Sequence Number: 16597745
• Product Code: LGW
• UDI-Device Identifier: 00643169887916
• UDI-Public: 00643169887916
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 02/09/2022
• Device Model Number: 3888-56
• Device Catalogue Number: 3888-56
• Device Lot Number: VA1P0WT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/13/2018; 07/05/2018; 08/08/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/25/2018; 07/17/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR