MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problem Low impedance (2285)

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

Event Date 04/21/2015

Event Type  Injury  

Event Description

It was reported that low impedances were measured on the extension.Impedance was measured to be 37 ohms on electrodes 2 and 3.During the procedure, impedances of the lead were tested with an external neurostimulator (ens) and found to be normal.The healthcare professional (hcp) decided to replace the extension.After the extension was replaced, all impedances were measured to be normal.There were no patient symptoms or complications associated with the event and the patient was fine.The patient was under general anesthesia during the procedure.

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: 2015-(b)(6), product type: extension.Product id: 3389s-40, lot# va0udn4, implanted: 2015-(b)(6), product type: lead.Product id: 3389s-40, lot# va0u2lt, implanted: 2015-(b)(6), product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: 2015-(b)(6), product type: extension.(b)(4).Analysis of the extension ((b)(4)) found no anomaly.A short could not be found in the extension.The measured impedance per circuit of the extension was 15 ohms.A short in the extension would need to be 30 ohms or less, unless the short is erratic or intermittent.The field reported impedance of the short between circuits #2 and #3 was 37 ohms.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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 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: 4763065
• MDR Text Key: 5791401
• Report Number: 3004209178-2015-08852
• 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: 04/21/2015

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: 07/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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: 00064 YR