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

Model Number	977A260
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
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 healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient didn't like having a rechargeable battery so the decision was made to replace it with a non-rechargeable battery.During the replacement, intra-op impedance testing showed all impedances were open.The hcp opened another new ins and again all impedances were open.The leads were tested with a wens and all impedances were open.The leads were replaced with two new leads and all impedances were then normal.The rep didn't know what led to the issue.The issue was reported to be resolved.The explanted leads were expected to be returned for analysis.No further complications were reported.
Additional Manufacturer Narrative
Analysis of the lead (s/n: (b)(4)) found all conductors were broken 22 cm from the proximal end.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: 9139912
• Report Number: 2649622-2019-17712
• Device Sequence Number: 1782861
• Product Code: LGW
• UDI-Device Identifier: 00643169109391
• UDI-Public: 00643169109391
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: 12/08/2019
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Device Lot Number: VA12DR3018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 02/11/2020
• 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