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

Model Number	977A260
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Refer to manufacturer report #2649622-2018-16678 for details pertaining to the reportable related event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported one of the lead stylets was twisted/spiraled when pulled out of the lead when removed from the packaging.The manufacturer representative couldn¿t remember which lead had this issue.It was noted that the stylet would be sent back for analysis.No symptoms or complications were reported.
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 representative.It was reported that the stylets were sent back for testing.They noted that everything was fine during the procedure and with the patient- just the stylet twisted/spiraled while the physician was removing it and it didn't do anything with the implanted lead.No further complications reported.
Additional Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: neu _stylet_acc, product type: accessory.Product id: neu_stylet_acc, product type: accessory.Analysis of the stylets found that they were bent.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7961292
• Report Number: 2649622-2018-16682
• Device Sequence Number: 1215008
• Product Code: LGW
• UDI-Device Identifier: 00643169109391
• UDI-Public: 00643169109391
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2019

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: 05/24/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/13/2018; 01/03/2019
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 10/24/2018; 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1