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

Model Number 977A260

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Refer to manufacturer report #2649622-2019-02372 for details pertaining to the reportable related event.If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider (hcp).The patient's information was updated.No further complications reported.

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.

Manufacturer Narrative

Product analysis #241375532: analysis information -- 2019-03-27 12:45:56 cst pli# 30 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.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8336080
• MDR Text Key: 136037531
• Report Number: 2649622-2019-02373
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00763000006501
• UDI-Public: 00763000006501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 136