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

Model Number	387360
Medical Device Problem Codes	Difficult to Insert (1316); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: neu_stylet_acc, serial#: unknown, product type: accessory.Product id: neu_e piduralneedle, lot#: unknown, product type: accessory.Device evaluation: analysis of the lead found a stylet perforated the lead¿s stylet coil 9.4 cm from the distal end.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 the lead was always bent in the epidural space during the implant surgery.When the surgeon considered replacing the guide wire, he found that only two-thirds of the guide wire could be put in and the tip of the lead was not bent.Repeated attempts failed to insert the guide wire completely into the lead.The lead was replaced as a result of the event and the issue was resolved.It was noted there were no physical issues observed with the lead or guidewire and the cause of the inability to fully insert the guidewire into the lead was not determined.There were no external factors reported that may have led or contributed to the issue.There were no further complications reported or anticipated.

• Brand Name: SPINAL CORD STIMULATION LEAD
• 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: 9781023
• Report Number: 2649622-2020-04402
• Device Sequence Number: 13593044
• Product Code: LGW
• UDI-Device Identifier: 00643169157385
• UDI-Public: 00643169157385
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: 06/07/2023
• Device Model Number: 387360
• Device Catalogue Number: 387360
• Device Lot Number: VA20D4S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR