MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problem Shaking/Tremors (2515)

Event Date 11/19/2014

Event Type  Injury  

Event Description

It was reported that two weeks after a replacement surgery the patient went to see their health care provider (hcp) because ¿one side was not working¿.After discussing with their hcp it was determined that one side of the device had not been checked in the operation room and that there were high impedances.Their device was reprogrammed to a high setting which was helping some but they were still shaking.They noted that the shaking never went away but was better prior to their replacement.The patient¿s desire was to have a revision done however nothing had been planned.No intervention or outcome was provided however additional information has been requested and if received, a follow-up report will be sent.

Event Description

Additional information received reported the patient was going to have an x-ray the week of the date of this report and then meet with their healthcare professional the week following the date of this report.It was noted that at the appointment a determination will be made on the next steps.

Event Description

Additional information received reported that the revision had not yet occurred.The manufacturing representative was seeing the patient with their healthcare professional on (b)(6) 2015 to determine the next steps.

Event Description

Additional information received reported the patient had a battery replacement case done and at the case they had checked impedances.A couple of weeks after the case the patient had a return of symptoms and had issues with impedances.

Event Description

Additional information received reported the patient was scheduled for a full system revision on (b)(6) 2015.

Manufacturer Narrative

Concomitant medical products: product id: 37092, lot# 301950001, implanted: (b)(6), 2012, product type: accessory.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3387s-40, lot# v670473, implanted: (b)(6) 2012, product type: lead.Product id: 3387s-40, lot# v681753, implanted: (b)(6) 2012, product type: lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4428427
• MDR Text Key: 5279334
• Report Number: 3004209178-2015-00875
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Date Device Manufactured: 08/15/2014
• 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: 00050 YR