MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It was reported that a patient was not able to adjust stimulation and the programmer displayed the ¿call your doctor¿ icon and an out of regulation (oor) condition.This occurred the prior week.The patient called her healthcare provider (hcp) about the issue and was told to try turning the implantable neurostimulator (ins) on/off to try to clear the message.The patient was nervous to do this on her own and feared she wouldn¿t get it back on.The patient had a loss of therapeutic effect that began a couple of days prior to the report.The patient couldn¿t remember how to use the patient programmer and was trying to make an adjustment down but thought she accidently turned it up.The patient stated that she probably hit buttons she shouldn¿t have and thought she turned down one side and not the other.She had thought she turned down both sides but clearly she didn¿t.The patient was feeling shaky.She used the programmer and had a hard time connecting.She saw that the device was on, ok, and at 3.1 volts and 3.3 volts.The patient changed her settings so they were both them same and at 3.3 volts.She was able to clear the oor message.Later the day of the report, there was another oor condition and the patient wasn¿t able to adjust stimulation.She had an appointment scheduled with her doctor.No outcome was reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot# v245967, implanted: (b)(6) 2009, product type lead; product id 3387s-40, lot# v239714, implanted: (b)(6) 2009, product type lead; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type extension; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type extension; product id 64002, lot# n347295, implanted: (b)(6) 2013, product type adapter; product id neu_ptm_prog, serial# unknown, product type programmer, patient.(b)(4).

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 4138239
• MDR Text Key: 4932547
• Report Number: 3004209178-2014-18238
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2014
• Date Device Manufactured: 02/21/2013
• 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 Age: 00057 YR