MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 3387S-40

Device Problem Low impedance (2285)

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

Event Date 12/17/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 3708660, serial# (b)(4), product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).

Event Description

A health care provider (hcp) reported via a manufacturing representative that during a stage two implant, a short was measured on contacts 9 and 11.The hcp wiped down the lead contacts, sucked out fluid from the extension, and reconnected the lead and extension.The hcp also checked the extension and implantable neurostimulator (ins) connection.Impedances were checked again and contact 8 on the right side had high impedances with all pairings.The hcp checked the connections again, but impedances remained the same.A new extension was used, but impedances still remained the same.The manufacturing representative believed the cause of the short was the end of the lead from the stage one procedure and the cause of the high impedances were fluid and tissue in the distal end of the extension.This was considered user error since only the short was originally measured.The hcp kept disconnecting and reconnecting the extension and lead in an attempt to correct the short and that was when they saw the high impedances.The hcp decided it was fine to proceed, close the patient, and notify the manufacturing representative and neurologist, who would be programming the ins, to program around the short.It was unknown if the issue was resolved.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5360405
• MDR Text Key: 35667420
• Report Number: 6000153-2016-00088
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2018
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA0XBSV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/12/2016
• Date Device Manufactured: 06/30/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 00012 YR