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

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 64002, lot# n329954, implanted: (b)(6) 2012, product type adapter.Product id 37642, serial# (b)(4), product type programmer, patient.Product id 3389s-40, lot# v476627, implanted: (b)(6) 2010, product type lead.Product id 37651, serial# (b)(4), product type recharger.Product id 3389s-40, lot# v455934, implanted: (b)(6) 2010, product type lead.Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type extension.Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type extension.(b)(4).

Event Description

The patient was implanted for dystonia.The manufacturing representative reported that the patient could not charge her device and there was a confirmed overdischarge.It was unknown how long the device had been in overdischarge.The reps could reportedly not restart the device.No interventions or outcomes were reported regarding this event.Further follow-up is being conducted to obtain this information.

• 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: 5001547
• MDR Text Key: 24308314
• Report Number: 3004209178-2015-15987
• 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,consum
• Reporter Occupation: Other
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2015
• Date Device Manufactured: 04/26/2012
• 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: 00065 YR