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

Model Number	3777-45
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2018
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
The healthcare professional (hcp) reported through a manufacturer representative that two ¿faulty¿ leads were experienced.It was noted the leads were found to be faulty prior to implant.The lead with serial number (b)(4) was opened, the stylet was changed, and prior to implant it was found to have a frayed contact end.It was noted the second lead had the same issue.Neither lead was implanted as a result of the issue.A different lead was ultimately implanted instead.It was noted the patient¿s weight was unknown, but the patient was not considered obese.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the manufacturer representative (rep) involved with the event noted she was at the implant when the leads were open, but she was unsure of the exact date of the procedure.The rep noted that she thought the date was (b)(6) 2018 and that she believed both leads involved the same patient.No further complications were reported or anticipated.Please see manufacturer report #3007566237-2018-01004 for information regarding the other lead.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.¿ please see regulatory report #3007566237-2018-01004 for information regarding the other lead.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: analysis of the lead found an epoxy fragment protruding from the surface of the lead between the #1 and #2 electrodes.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: LEAD FOR SPINAL CORD STIMULATION
• 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: 7404405
• Report Number: 2649622-2018-02866
• Device Sequence Number: 18841037
• Product Code: LGW
• UDI-Device Identifier: 00643169157538
• UDI-Public: 00643169157538
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/22/2018

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: 08/12/2021
• Device Model Number: 3777-45
• Device Catalogue Number: 3777-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 05/02/2018; 06/05/2018; 09/26/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/24/2018; 05/31/2018; 06/25/2018; 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1