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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Unstable (1667); Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: 37791, product type: recharger.Product id: 37651, serial# (b)(4), product type: recharger.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the patient had a difficulty recharging as there was intermittent poor coupling for the past couple of weeks and the past weekend.The manufacturer representative (rep) met with the patient on this past monday and could not get above 4 coupling bars with the patients implantable neurological stimulator recharger (insr).It was confirmed that they tried turning the antenna dial, but the issue was not resolved; the antenna was noted to be damaged.The rep tried a different insr and was immediately able to get full coupling; it is unknown if a different antenna was also used.A replacement antenna was sent.It was later reported that the device was taking too long to charge as the coupling was fluctuating; the rep stated the replacement antenna was not tried.It was confirmed that patient was not moving or changing positions and the implantable neurostimulator (ins) was connecting to the clinician programmer 8840 and the patient programmer.Repositioning the antenna would initially resolve the issue, but after 2-5 minutes, coupling would slowly fade away.An antenna locate procedure was performed and the rep got as high as 80 with a range of 64-80.The rep then reported that the patient has access to another insr, but that did not resolve the issue.The rep stated that applying some pressure to the antenna while it was positioned over the ins seemed to work, but if he lifted the pressure, coupling would again begin to fade.It was confirmed that there were no pocket issues related to the ins.It was reported that the patient experienced a loss of stimulation in (b)(6) 2016 due to the inability to keep the ins charged because it was taking 6 hours every day to charge the device.The patient's health care provider (hcp) later reported the patient's ins was at an angle and they had trouble charging the ins since implant.The hcp wanted to know what would show up if the patient was in overdischarge.As of (b)(6) 2016, the hcp was able to interrogate the ins to see that it needed to be recharged so the ins was not overdischarged.

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: 5897775
• MDR Text Key: 52844206
• Report Number: 3004209178-2016-17504
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• Date Device Manufactured: 02/04/2015
• 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: 60 YR