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

Model Number 748240

Device Problems Electromagnetic Interference (1194); Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

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

Event Date 08/27/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 37612, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id 64001, lot# n312790, implanted: (b)(6) 2012, product type: adapter.Product id 3387-40, lot# j0455228v, implanted: (b)(6) 2005, product type: lead.(b)(4).

Event Description

The healthcare provider (hcp) reported via a manufacturer representative (rep) that the patient went for a mammogram on (b)(6) 2015 and when she was walking to the parking garage she started experiencing an electrical sensation in her right arm, then her left foot.Her head was also pulling to the left.High impedances were seen on her right implantable neurostimulator (ins) on combinations case <(>&<)> 0 and 0 <(>&<)> 3.The nurse saw the patient several times and tried programming around the high impedances.The therapy impedance was high as well.X-rays were taken and visualized a crack in the lead.The patient was getting some benefit, but would need surgery to replace the cracked lead.The patient had an appointment scheduled for (b)(6) 2015 to discuss the replacement.There was no surgery date yet.Additional information received from the manufacturer representative (rep) reported that the surgery date was still not determined.The rep noted that the mammogram tech caused the lead to break.Additional information received from the manufacturer representative (rep) reported that the patient had the right lead and right extension replaced on (b)(6) 2016.Her extension was replaced because it got pulled down from the mammogram.There was nothing wrong with the extension though.The healthcare provider (hcp) just did not want the old extension to put too much tension on the lead, so that was the reason for replacement.The patient's device was turned on after the procedure and she was receiving therapy.All of the impedances were within normal limits.Refer to manufacturing report #3004209178-2015-21889 as the lead issue was originally system reported.The patient's indications for use were dystonia and movement disorders.

• Brand Name: DBS EXTENSION
• 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: 5389516
• MDR Text Key: 36804321
• Report Number: 6000153-2016-00212
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2008
• Device Model Number: 748240
• Device Catalogue Number: 748240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• 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: 00063 YR