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

Model Number 37602

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was noted that the shocking was very brief but very reproducible, and there was some paraesthesia on that side as well.

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient had a shocking or jolting sensation.Since the patient¿s implantable neurostimulator (ins) was replaced in (b)(6) 2013 the patient had experienced significant shocks every time the ins was turned off with the patient programmer or during reprogramming.The healthcare professional (hcp) observed the shocks the day prior to this report when they were reprogramming the patient.The hcp stated the shocks were severe and lasted less than a couple seconds.The shocks were more severe when the ins was turned on.The patient felt the shocks on the left side of their face, arm, and leg.The hdp did not decrease stimulation before turn the ins off because it happened during reprogramming when they were changing the electrode configuration and the amplitude automatically dropped down to zero.The patient felt the shocks when the stimulation was at 0.0v.The hcp stated that impedances may have been a little on the low side around 700-800 ohms, but nothing out of range.The patient was programmed at c+, 1- at 3.5v, pulse width of 90, and a rate of 130 hz.The patient had previously been programmed at 4.0v and a pulse width of 90.The ins was not programmed using interleaving and the ins was in voltage mode.Bipolar programming had not been tried.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 3387s-40, lot# v311441, implanted: (b)(6) 2010, product type: lead; product id 37642, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.(b)(4).

• 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: 4393408
• MDR Text Key: 5358188
• Report Number: 3004209178-2015-00242
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Date Device Manufactured: 07/13/2012
• 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: 00064 YR