MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3387S-40

Device Problems Break (1069); Low impedance (2285)

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

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Product id: 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 37601, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.(b)(4).

Event Description

Information was received from a company representative regarding a patient who was implanted with an implantable neurostimulator (ins) for obsessive compulsive disorder (ocd) and movement disorders.It was reported impedance measurements were taken and therapy impedance was 450 ohms; c/0 3115, c/1 523, c/2 1887, c/3 519, 0/1 2846, 0/2 4083, 0/3 2846, 1/2 1423, 1/3 35, and 2/3 1287 ohms.The extension on the one side felt tight and they had above impedance on that same device.They did not know which side the issue was on.There was tightness along the extension and in their neck.Additional information received one week later from the health care professional (hcp) reported an x-ray was taken and it identified a lead break above the connector.The cause of the tightness in their neck was a lead break.The patient's device would be explanted and the device would be replaced in (b)(6) 2015.Please see manufacturer report #6000153-2015-00483 for information on the patient's concomitant system.

Event Description

Additional information received reported the surgery had been delayed due to insurance dispute.Surgery was tentatively scheduled for the month of (b)(6) 2016 but all depended on insurance so there was no device yet.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 5294435
• MDR Text Key: 33427983
• Report Number: 6000153-2015-00485
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2015
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA062UF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2016
• Date Device Manufactured: 01/15/2013
• 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: 00029 YR