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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
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 representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the physician was implanting the lead and when they went to remove the stylet from the end portion of the lead, the lead came out completely.No known factors led to the issue and the lead was not used.The lead came out from the box and was not used.The lead was said to be defective.The lead was going to be returned for analysis.No symptoms or further complications were reported.
Additional Manufacturer Narrative
Analysis of the lead has not yet begun.A follow up report will be submitted once analysis is completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the lead found that the outer insulation was separated at a butt joint at the proximal end.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: 8243859
• Report Number: 2649622-2019-00734
• Device Sequence Number: 2287720
• Product Code: LGW
• UDI-Device Identifier: 00643169887909
• UDI-Public: 00643169887909
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

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: 10/23/2022
• Device Model Number: 3888-45
• Device Catalogue Number: 3888-45
• Device Lot Number: VA1VRBF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/11/2019; 02/06/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 01/23/2019; 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1