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

Model Number 37601

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 06/14/2015

Event Type  Injury  

Event Description

Additional information received from the manufacturer representative (rep) reported that the shocking occurred on the patient¿s right side, or left brain.It was in the right shoulder and arm and considered sudden.It started on (b)(6) 2015 and occurred daily.Impedance measurements were taken and a short circuit was found on the electrode combination of 0 and 2.It was 90 ohms and the combination was being used in programming.In addition, the lead placement on that same side was not optimal, so an intended lead revision was scheduled for (b)(6).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.(b)(4).

Event Description

It was reported there was a shocking/jolting sensation over their whole body for a few seconds two times within the same hour between 9-10am the day prior to report.The patient was in the bathroom and reached towards the medicine cabinet when it occurred.It had not occurred since and he never lost therapy.The battery was interrogated with his neurologist on the day of report.Impedance testing was performed and the results were normal and the device usage showed 100%.They had the patient move their head and arms and could not reproduce the symptom.No actions were taken.The patient was instructed to turn off the device if it ever became uncomfortable.The patient did not want to turn it off and lose the therapeutic benefits.

• 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: 4892107
• MDR Text Key: 16652358
• Report Number: 3004209178-2015-12793
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• Date Device Manufactured: 06/29/2012
• 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
• Patient Age: 00082 YR