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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193)

Event Date 07/14/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# v561099, implanted: (b)(6) 2011, product type: lead.Product id: 3389s-40, lot# v561099, implanted:(b)(6) 2011, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.(b)(4).

Event Description

The healthcare professional of a clinical study reported that there that the patient experienced capsular activation.The patient was to have the lead moved from subthalamic nucleus (stn) to gip's in order to escape capsular effects in stn.The surgery is being planned for november.The outcome was noted as an ongoing event.The patient experienced cramping pain at voltages around 2 or lower.The patient experienced right wrist and right foot cramping pain with stimulation.The etiology was noted as lead/extension tract.The event was related to the device or therapy and possibly related to the implant procedure.The severity was noted as mild.

Event Description

Additional information received reported the left subthalamic nucleus (stn) was replaced with left gloubus pallidus intermediate (gpi) lead on (b)(6) 2015.The outcome was resolved without sequelae.

• 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: 5005138
• MDR Text Key: 23089679
• Report Number: 3004209178-2015-16082
• 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,study
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/21/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Date Device Manufactured: 10/28/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 00055 YR