MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Cramp(s) (2193)

Event Date 03/24/2015

Event Type  malfunction  

Manufacturer Narrative

Product id: 37612, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 37612, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 64001, lot# n484517, implanted: (b)(6) 2015, product type: adapter.Product id: 37651, serial# :(b)(4), product type: recharger.Product id: 64001, lot# n485661, implanted: (b)(6) 2015, product type: adapter.Product id: 37612, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3387s-40, lot# va07xlu, implanted: 2(b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va0a3a0, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer.Patient product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 37651, serial# (b)(4), product type: recharger.

Event Description

Information was received regarding a patient implanted for dystonia and movement disorders.It was reported the patient was having telemetry issues.The patient was able to once get eight coupling bars, but now they only got 4-6 bars.The patient was not able to charge the implantable neurostimulator (ins) more than 75 percent.The patient had been having coupling issues since implant.The antenna locate feature was tried and the manufacturing representative saw a baseline of 50 and a top number of 54.After the antenna locate feature was used, the patient tried to charge at the position, but they were only able to get two bars.The patient's healthcare professional (hcp) had noted some swelling around the ins at a recent appointment.The patient mentioned the surgeon had done a lot of cutting on the side opposite of the ins.The manufacturing representative mentioned the patient's hand cramped when holding the charger over the ins and slight movements caused a decrease in coupling bars.The patient was trained and able to demonstrate effective charging.The ins was programmed in continuous mode.The cause of the event was determined to be post operation swelling.The patient later reported that they started to charge the recharger, but then it started beeping and it would not stop.A hard reset of the recharger was not able to be done at the time of this report.The patient was only getting 2-4 coupling bars and recharging was taking a long time.At the time of this report, the patient was able to get four coupling boxes.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, the event will be updated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5614700
• MDR Text Key: 43878736
• Report Number: 3004209178-2016-08450
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: 04/09/2015
• Supplement Dates FDA Received: 09/21/2017
• Date Device Manufactured: 03/10/2015
• 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: 55 YR