MAUDE Adverse Event Report: MPRI PERCUTANEOUS LEAD FOR SCS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	3778-75
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Component Misassembled (4004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
It was reported that the guide wire was shorter than the lead by more than 10 cm.It was found that there was no guide wire at the most front-end, the lead couldn't be implanted.The device couldn't be used due to inappropriate accessories.The aseptic conditions had been destroyed, and the lead couldn't be used again.No environmental/external/patient factors were reported that may have led or contributed to the issue.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Concomitant medical products: product id: neu_stylet_acc, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the stylet found the stylet was 60 cm long, but should have been 75 cm long.Analysis identified that the wrong part was packaged in the lead kit.(b)(4).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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCUTANEOUS LEAD FOR SCS
• 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: 7741310
• Report Number: 2649622-2018-12610
• Device Sequence Number: 1084445
• Product Code: LGW
• UDI-Device Identifier: 00643169157354
• UDI-Public: 00643169157354
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/19/2018

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: 05/17/2021
• Device Model Number: 3778-75
• Device Catalogue Number: 3778-75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 09/13/2018; 08/08/2018; 11/08/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/31/2018; 09/28/2018; 10/03/2018; 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1