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

Model Number	977A275
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
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
Information was received from a manufacturer representative regarding a patient who was having a spinal cord stimulation system implanted on the day of the report.It was reported that the lead was implanted during a standard new implant procedure.When the lead was tested, an impedance test showed that contacts 8, 9 , 12, 13, 14, and 15 all had a possible short/open contact.The lead was removed without incident and replaced with a new lead.There were no external factors noted to have caused the issue.Replacing the lead resolved the issue.There were no patient symptoms or complications reported.
Additional Manufacturer Narrative
Analysis of the lead found no anomaly.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: 9272062
• Report Number: 2649622-2019-20193
• Device Sequence Number: 114628
• Product Code: LGW
• UDI-Device Identifier: 00763000006525
• UDI-Public: 00763000006525
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: 11/29/2022
• Device Model Number: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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