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

Model Number 37612

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that the patient was having random shocking pain on and off through the whole body but mainly behind the ¿wire¿ in her neck about half an inch behind the wire.It was noted that this had been going for a couple of months prior to the date of this report.It was further noted that the last couple of weeks prior to the date of this report the shocking pain seemed to have gotten pretty bad.The patient had botox about a month prior to the date of this report which seemed to have helped the shocking pain.Impedance levels were tested at the end of (b)(6) 2014 when the patient had the botox and impedance levels were fine.It was noted that the patient never seemed to get better for very long.Patient was on their way to the emergency room because of the shocking pain at the time of this report.It was later reported that there was a shocking or jolting sensation.The patient had lead replacement surgery on (b)(6) 2014.Additional information was requested but had not been received as of the date of this report.

Manufacturer Narrative

Concomitant products: product id 3708640, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # v270501, implanted: (b)(6) 2010, product type lead; product id 3708640, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3387s-40, lot # v270501, implanted: (b)(6) 2010, product type lead; product id 37651, serial # (b)(4), product type recharger; product id 37642, serial # (b)(4), product type programmer, patient; product id 3387s-40, lot # v270501, implanted: (b)(6) 2010, product type lead; product id 3387s-40, lot # v270501, implanted: (b)(6) 2010, product type lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id 3387s-40, lot# v270501, implanted: (b)(6) 2010, product type: lead.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id 3387s-40, lot# v270501, implanted: (b)(6) 2010, product type: lead.Product id 37651, serial# (b)(4), product type: recharger.Product id 37642, serial# (b)(4), product type: programmer, patient.Product id 3387s-40, lot# v270501, implanted: (b)(6) 2010, product type: lead.Product id 3387s-40, lot# v270501, implanted: (b)(6) 2010, product type: lead.(b)(4).

Event Description

Additional information received reported that the patient would feel shocking on the same side of extensions that would originate on the left neck and radiate into the left arm.It would sometimes last for as long as 1 minute and would occur 3 to 5 times a day.Therapy had been less effective over time.The patient and her parents believed that the patient had grown significantly since original implant and had a couple of concussions which may have contributed to both issues.The patient was in the process of seeking consultation to consider lead revision and replacement of the entire system.Impedance testing was done.The patient was alive with no injury.No intervention or outcome was provided regarding the event.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

• 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: 3764000
• MDR Text Key: 18921239
• Report Number: 3004209178-2014-07629
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• 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: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2014
• Date Device Manufactured: 09/09/2010
• 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: 00010 YR