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

Model Number	387360
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Receipt by User (1570); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id neu_stylet_acc, lot #: unknown, product type: accessory.Report source: (b)(6).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the lead had burrs and that the lead burrs were identified after the lead was in the patient.It was stated that after the puncture was completed, it was found the lead position could not be adjusted during lead delivery.The lead was replaced after the problem was found and the issue was resolved.It was noted that a surgical intervention was required to replace the lead and complete the surgery.The lead issue was considered an out of box issue, as it the position could not be adjusted during the first time placement.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
Product id: neu_epidural needle, lot# unknown, product type: accessory; product id: neu_stylet_acc, lot# unknown, product type: accessory.Device evaluation: analysis of the lead found the lead¿s outer insulation was cut and that the finding was consistent with needle damage.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: LEAD
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8995049
• Report Number: 2649622-2019-16438
• Device Sequence Number: 235466
• Product Code: LGW
• UDI-Device Identifier: 00643169157385
• UDI-Public: 00643169157385
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: 387360
• Device Catalogue Number: 387360
• Device Lot Number: VA1R57E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention