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

Model Number	3487A-56
Medical Device Problem Codes	Material Perforation (2205); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A manufacturer representative (rep) reported that when the physician attempted a trial for the patient, they could not advance the lead midline, it kept going to the left.The physician used a blank and they still could not get the lead midline or advance to the intended area.The procedure was not completed so the physician planned to use a buried lead trial but the stylet was sticking out of the lead superior to the distal contact.It was noted that the issue was resolved at the time of thereport, surgical intervention did not occur and it was not planned.There were no reports of medical or therapy issues and no patient symptoms reported.Follow-up is not required at this time and there is no further information related to this event.
Event or Problem Description
No new information reported.
Additional Manufacturer Narrative
Analysis of the lead found that the stylet wire perforated the outer insulation at the distal edge of the #1 electrode sleeve.The lead was noted to be electrically okay.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a health care provider via a manufacturer representative.It was reported that these leads came with the stylets already seeded.This was not bent additionally by the physician.No issues were noted with steering, and the health care provider was not concerned about the lead or the stylet.No patient symptoms or complications were reported.
Additional Manufacturer Narrative
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: 6296359
• Report Number: 2649622-2017-00074
• Device Sequence Number: 16302367
• Product Code: LGW
• UDI-Device Identifier: 00613994300478
• UDI-Public: 00613994300478
• 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,Followup,Followup
• Report Date (Section B): 04/27/2017

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: 09/09/2020
• Device Model Number: 3487A-56
• Device Catalogue Number: 3487A-56
• Device Lot Number: VA1ACFK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; 04/27/2017; 04/27/2017
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 02/08/2017; 03/30/2017; 04/27/2017; 09/29/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1