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

Model Number 977A260

Device Problem Positioning Problem (3009)

Patient Problems Muscle Weakness (1967); Spinal Cord Injury (2432)

Event Date 08/22/2019

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 health care provider (hcp) via a manufacturer representative regarding a patient who was implanted with a neurostimulator.It was reported that the patient had a replacement surgery on (b)(6) 2019 where the ins and lead were explanted successfully but the healthcare provider (hcp) was unable to place a new paddle lead.On 2019-aug-28 the manufacturer representative found out that the patient had a bruised spinal cord and was experiencing leg weakness as a result of the surgery.It was unknown what interventions were taken.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 7427, serial# (b)(4), implanted: (b)(6) 2004: explanted: (b)(6) 2019, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep) reporting that the cause of the healthcare provider (hcp) not being able to place the new lead was per the surgeon, the patient¿s spinal anatomy did not allow for placing a new lead.It was indicated that the surgeon was dealing with the patient¿s bruised spinal cord and leg weakness directly and the rep had indicated that they had not been made aware of how they were addressing this.It was indicated that the lead that was unable to be implanted had been discarded.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba,pr TN 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr TN 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8949972
• MDR Text Key: 156160369
• Report Number: 1030489-2019-00958
• 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
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2019
• Date Device Manufactured: 05/30/2019
• 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: 60 YR