MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VANTA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 977006

Device Problems High impedance (1291); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2013, product type: lead, product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Other relevant device(s) are: product id: 39565-30, serial/lot #: (b)(4), ubd: 20-sep-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via manufacturer representative who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient was seen for post-op on (b)(6) 2021, and impedances were over 40,000 ohms on the 8-15 side of the paddle.Only 11 was okay.Reprogramming was attempted to try and offer him right back and leg relief despite the impedances.The patient will report back if they are getting good coverage, or will take the next steps for a possible lead revision.The patient didn't report any notable fall or accident which may have caused the issue.The patient is getting some relief.At this time, the health care professional has no further information regarding the event.Surgical intervention was not performed at this time; however, the patient was referred to their neurosurgeon.

• Brand Name: VANTA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12478909
• MDR Text Key: 271672154
• Report Number: 3004209178-2021-13920
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00763000411923
• UDI-Public: 00763000411923
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 977006
• Device Catalogue Number: 977006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention