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

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that there was a shocking or jolting sensation from head to toe, the patient felt a ¿zing¿ go through her on the prior to the date of this report about 4pm while reading.There was a loss of therapeutic effect and the patient was shaking all over.The shaking had started on the day prior to the date of this report at 4pm.The patient had charged her implantable neurostimulator (ins) on thursday prior to the date of this report and on the night prior to the date of this report because on sunday prior to the date of this report the battery was showing empty.It had taken 3 hours to charge on the day prior to the date of this report but the patient had fully charged it.The patient programmer showed stimulation was on.The patient had met with their manufacturing representative on (b)(6) and troubleshooting included palpation and impedance measurements were done without shocking sensation.Initial patient settings were 4.9v left and 5.1v right.The manufacturing representative believed the shocking was due to the ins being turned on at such high amplitude settings, the patient was reprogrammed to a bipolar mode with lower amplitudes, a range of 3.5v.The patient was implanted for multiple sclerosis tremors which can be multifocal.The manufacturing representative had thought the device was possibly shut down due to her needing to recharge.Following the reprogramming the patient was received good efficacy at lower settings.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va02kcc, implanted: (b)(6) 2012, product type: lead; product id 3387s-40, lot# va012tp, 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(b)(6) extension; product id 37651, serial# (b)(4), product type: recharger.(b)(4).(b)(6).

• 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: 4386846
• MDR Text Key: 16305189
• Report Number: 3004209178-2015-00176
• 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
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• Date Device Manufactured: 09/23/2014
• 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 Age: 00071 YR