MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that there was a coupling problem.An implantable neurostimulator (ins) overdischarge was suspected.The patient had not been getting any coupling boxes shaded in, all were blank.It was noted that it had started almost a year prior to the date of this report.Last successful recharge and when the patient last saw boxes shaded was 6 months prior to the date of this report.Stimulation was last felt 6 months prior to the date of this report.Additional information was requested but had not been received as of the date of this report.

Manufacturer Narrative

Concomitant medical products: product id 3389-40, lot# v001294, implanted: (b)(6) 2006, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension; product id 64001, lot# n259554, implanted: (b)(6) 2010, product type: adapter; product id 3389-40, lot# j0546567v, implanted: (b)(6) 2006, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2006, product type: extension; product id 37092, lot# 240620002, implanted: (b)(6) 2010, product type: accessory; product id 64001, lot# n259547, implanted: (b)(6) 2010, product type: adapter; product id 37651, serial# (b)(4), product type: recharger; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37612, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3970789
• MDR Text Key: 4747900
• Report Number: 3004209178-2014-13745
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 07/31/2014
• Date Device Manufactured: 08/30/2010
• 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 Age: 00084 YR