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

Model Number 37602

Device Problem High impedance (1291)

Patient Problem Cognitive Changes (2551)

Event Date 03/17/2015

Event Type  Injury  

Event Description

It was reported the patient was admitted to this hospital for a mental change and a kidney infection.The patient¿s healthcare professional (hcp) wanted a manufacturing representative to check to make sure the device was still functioning properly.The implantable neurostimulator (ins) was programmed on the left to 0-, 3+ at 4.8v, 60 us, and 160 hz.Therapy impedance on the left side was measured to be 2638 ohms.Impedances on the left side, run at 1.5v, were measured to be high with impedance of 2773 ohms being measured on electrode pair c-0.The left ins battery voltage was measured to be 2.98v.The right ins was programmed to 1-, 3+ at 4.5v, 60 us, and 180 hz.Therapy impedance on the right side was measured to be 2538 ohms.Impedances on the right side, run at 3v, were measured to be high on electrodes c-0, c-3, and 0-3.The right ins battery voltage was measured to be 2.87v.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389-40, lot# j0406024v, implanted: (b)(6) 2004, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).

Event Description

Additional information received reported the implantable neurostimulator (ins) was checked by a manufacturing representative while the patient is in a hospital to make sure it was working.No problems were found with the ins and the healthcare professional's goal was to rule out a deep brain stimulation problem as a cause of the patient's decline.No actions were taken and the issue was not device related.

• 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: 4664551
• MDR Text Key: 5624262
• Report Number: 3004209178-2015-06062
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2015
• Date Device Manufactured: 04/04/2013
• 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): Hospitalization
• Patient Age: 00077 YR