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

Model Number 977A260

Device Problems Break (1069); Difficult to Insert (1316); Difficult to Remove (1528)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) via a manufacturer representative.It was reported that while placing the lead, the lead appeared to be hung up on the tip of the needle.It appeared that the lead was stuck in the needle and would not advance or retract.Once the lead was removed from the needle with some effort, there was slight tear in the silicone coating on the lead between some of the contacts.A new lead was opened and used instead.There was no patient involvement and no symptoms or complications were reported.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.The representative reported that the device was shipped back for analysis.No symptoms or complications were reported.

Manufacturer Narrative

Analysis of the electrical lead found that the outer insulation was cut.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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 MN 00766 1200
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr MN 00766 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7105711
• MDR Text Key: 95576539
• Report Number: 3007566237-2017-05129
• Device Sequence Number: 1
• Product Code: GZB
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Device Lot Number: VA1LREM018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• 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: 57 YR