MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problem Break (1069)

Patient Problems Dysphagia/ Odynophagia (1815); Muscular Rigidity (1968)

Event Type  Injury  

Event Description

It was reported that there was a left lead fracture adjacent to the stimloc.The action required as a result of the event was a replacement.Diagnostic testing and troubleshooting included impedance testing and x-rays.The issue was not resolved and the cause was not determined.Patient symptoms associated with the event were increasing dysphagia and rigidity in the left upper extremity.The location of the symptom was the lead location.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# va090aq, implanted: (b)(6) 2013, product type: lead; product id 3389s-40, lot# va08ytx, implanted: (b)(6) 2013, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4565375
• MDR Text Key: 5556361
• Report Number: 3004209178-2015-04048
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2015
• Date Device Manufactured: 10/24/2012
• 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): Required Intervention