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

Model Number 748251

Device Problem Low impedance (2285)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3387-40, lot# j0406229v, implanted: (b)(6) 2004, product type: lead.(b)(4).Analysis of the extension, serial #(b)(4), found the outer insulation had a breached depression.This exposed the #0 conductor 6.0 cm from the proximal end and exposed the #3 conductor 14.5 cm from the proximal end.The conductor was broken and had a coiled wire in the body.The #3 conductor filars were broken 36.0, 37.7, and 38.5 cm from the proximal end.The #2 conductor filars were broken 38.5 cm from the proximal end.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code 12 because it is the closest code available with respect to this event.

Event Description

The manufacturer representative (rep) reported that impedances were measured prior to a mri.A short circuit was apparent: the electrode combination of 0 <(>&<)> 1 came back 105 ohms and the therapy impedance was 247 ohms.There was no history of impedances for this patient.The implantable neurostimulator (ins) was also at the elective replacement indicator (eri).The mri was to prepare for second stage lead placement in the globus pallidus (gpi), but was not performed due to the short.There were no associated symptoms.The patient's indications for use were dystonia and movement disorders.Additional information received from a manufacturing representative reported the lead and extension site and the implantable neurostimulator (ins) site were opened during a revision to test the extension and the lead.No high impedances were measured when the lead was tested.The extension was replaced and a new ins was implanted.After replacing the extension and ins, all impedances were normal.Cause of the short was not known.The issue was resolved.Refer to manufacturing report #3004209178-2015-20775 for a report on the ins.The short was originally associated with the ins as no extension issue had been previously discovered.

• 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: 5366765
• MDR Text Key: 35969134
• Report Number: 6000153-2016-00109
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2016

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: 07/21/2008
• Device Model Number: 748251
• Device Catalogue Number: 748251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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