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

Model Number 37612

Device Problems Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problems Dysphagia/ Odynophagia (1815); Muscle Spasm(s) (1966); Dysphasia (2195); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient had a globus pallidus lead hooked up the right clavicular rechargeable device and a subthalamic nucleus lead hooked up to the left clavicular primary cell device.The patient was seen due to routine programming.There was poor globus pallidus outcome.The globus pallidus therapy was turned off due to side effects.It was noted that the patient still needed to recharge if the device was off.It was noted that the subthalamic nucleus was fine with no issues.(b)(6) 2014 lfc (hcp): additional information received reported the cause of the event was a misplaced globus pallidus lead or right brain.The lead was not in target, the right globus pallidus was planned.Patient had a brain mri in (b)(6) 2013 that showed the lead on the right was misplaced.The subthalamic nucleus was reprogrammed to optimize therapy and globus pallidus was turned off, (b)(6) 2013.Signs and symptoms associated with the event were slurred speech, severe muscle spasms, imbalance, and swallowing problems.The patient had not required hospitalization.Patient outcome was serious injury/ illness, recovered without sequelae.The patient had bilateral subthalamic nucleus that were effective stimulation.Side effects resolved when turned off the right lead and reprogramming the subthalamic to optimize therapy results.

Manufacturer Narrative

Concomitant medical products: product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v297034, implanted: (b)(6) 2009, product type: lead; product id 37601, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3389s-40, lot# v222841, implanted: (b)(6) 2009, product type: lead; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37651, serial# (b)(4), product type: recharger; product id 3389s-40, lot# v494243, implanted: (b)(6) 2010, product type: lead.(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: 3690537
• MDR Text Key: 4291098
• Report Number: 3004209178-2014-04735
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Date Device Manufactured: 07/20/2012
• 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 Outcome(s): Other
• Patient Age: 00052 YR