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

Model Number	977A260
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
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 by a manufacturer's representative regarding an implantable neurostimulator (ins).It was reported that the healthcare provider (hcp) was attempting to place a lead after a trial.The hcp attempted to bend the stylet outside of the lead and then couldn't reinsert it fully- it would only go to about the last one and a half inches.The hcp was pushing pretty hard on at least one of the leads.The case was aborted and the hcp tried three leads.No symptoms or further complications 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 a healthcare provider (hcp).The patient's information was updated.No further complications reported.
Additional Manufacturer Narrative
Product analysis #241375531: analysis information -- 2019-03-27 12:11:56 cst pli# 20 product id# 977a260 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.The returned device passed all testing in the laboratory and no anomalies were identified.Analysis of the lead serial# (b)(4) found no anomaly.(b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product id: neu_stylet_acc, lot# unknown, product type: accessory; product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator; product id: 977a260, serial# (b)(4), product type: lead; product id: 977a260, serial# (b)(4), product type: lead.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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: 8336054
• Report Number: 2649622-2019-02372
• Device Sequence Number: 19214110
• Product Code: GZB
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2019

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: 03/05/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/01/2019; 03/04/2019; 03/27/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/04/2019; 03/06/2019; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 136