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

Model Number 37602

Device Problems Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems High Blood Pressure/ Hypertension (1908); Shaking/Tremors (2515)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3389s-40, lot# v939343, implanted: (b)(6) 2012, product type: lead.Product id: 3389s-40, lot# v959668, implanted: (b)(6) 2012, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.(b)(4).

Event Description

A consumer with an indication for use of parkinson's dual and movement disorders reported an elective replacement indicator (eri) code being seen in (b)(6) 2015.Prior to the eri the patient had spent several early mornings shaking with high blood pressure which was why the patient checked the eri.There were no falls or traumas that were possibly related and no allegation against longevity or dissatisfaction with longevity.The device was on and patient was still receiving therapy but was experiencing symptoms of shaking which were reported as sudden in onset.According to the patient the event coincided with wearing a life alert necklace and eri message.The patient had an appointment scheduled for surgery on (b)(6) 2015 to replace the left side battery.Reference manufacturer's report number:3004209178-2015-17007 for patient's left side device that was being replaced.

• 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: 5042692
• MDR Text Key: 25290519
• Report Number: 3004209178-2015-17010
• 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
• Reporter Occupation: Other
• Report Date: 08/07/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Date Device Manufactured: 01/26/2012
• 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 Age: 00066 YR