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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer via a manufacturer representative regarding a patient with an implantable neurostimulator ( ins) for the treatment of parkinson's disease and movement disorders.It was reported the patient had a sudden return of symptoms and their hand was shaking.The rep reported the shaking began over the last few days but the patient stated it had been since the day after implant.It was reported the ins or the insr was not taking a charge.It was reported the event was not related to positional movement.Additional information was received stating it was taking too long to charge and the patient had poor coupling.The patient reported to the manufacturer representative his hands were shaking and clarified the ins was not charging.The rep reported the patient told him he had good coupling.But they put the ins recharger on him and after 2 hours his hands still had not calmed down even after 6-7 hours of charging.During the call the patient reported the ins recharger (insr) said it needed to be checked and had the reposition antenna screen.The patient connected and saw the charging screen and the ins showed on, ins half charged and 6 bars but then the bars were gone.The patient stated the insr never showed his ins charged to full.The patient reported he could charge for 6 hours and his hands would still shake and they shake all the time.They stopped shaking when he was at the hospital and when he came home after implant surgery but then were shaking the next day.It was reported he could not hold the insr, drink coffee, or do anything.The patient stated "the device is banging his face".The patient reported he did not have shaking issues with his previous device.The patient became very frustrated on the call and stated he could not charge and this had to go even if he had to "cut it off myself" and stated if he knew he had to wear it all the time he would have never kept the "stupid thing".The patient had an appointment with the surgeon and rep scheduled for the next day.The patient was sent adhesive disks for charging.The rep called back stating the original call stated the ins was on but the patient's daughter said the ins was off and the poor coupling continued with 6 bars but then they would disappear.It was reported the ins battery was low.It was reported the patient was charging over clothing and once the clothing was removed and the recharger antenna was repositioned the patient was getting 8 bars right away.A replacement recharger antenna was sent as a precaution.On (b)(6) 2018 i t was reported the patient was trying to charge and the insr displayed the normal charging screen but with 0 coupling bars.During the call antenna locate was used to determine best place for charging.The caller stated the insr was displaying 50-78-78 as the highest values.The caller started a recharging session and got 6 coupling bars the caller stated the coupling would drop to 4 without any obvious change in the antenna position.The patient stated they had never been able to get the insr to display the 100% charge level.The patient mentioned the shaking that he had and the rep clarified that occurred yesterday because the ins had been turned off.The caller stated that he had gotten adhesive patches to try to maintain the best position for recharging.The rep called back stating the coupling bars would go from 6 to 4 to 0.It was reported the patient was holding the recharger to charge and refused to use his holster.The caller reported opening a brand new recharger and getting 4 bars that dropped to 0.Antenna locate showed 54-58 and 60-68 with pressure applied.It was reviewed there may be some swelling post procedure affecting coupling.It was reported the patient just had the stitches removed on the day of the call and the site was well healed.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep confirming the issue had been resolved.It was reporting his swelling went down enough for the battery to couple with the device.The battery was able to be charged and turned on.The shaking and swelling had been resolved at the time of the report.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the cause of the shaking and poor coupling was due to the patient turning the battery off, and not realizing they turned it off.The rep.Further reported the issues had been resolved as it was determined that swelling after surgery was the cause of the coupling issue and would get better over time.However, that same day the consumer reported the patient continued to have poor coupling, the implantable neurostimulator (ins) was off, and the patient¿s hand was shaking.During the call it was confirmed the consumer was getting zero coupling boxes, stimulation was off, and the first quartile on the ins was flashing.Following this it was reviewed with the consumer stimulation was off because the ins battery was too low.Troubleshooting was performed including repositioning the antenna and placing the recharger on the skin.The consumer then stated they held the antenna with their hand because they needed to add pressure due to swelling.An attempt was made to walk through using the antenna locate feature, but the consumer was unable to follow the instructions, so the antenna dial was turned resulting in zero coupling boxes.It was noted that after the patient met with the rep.Previously they went home and tried to charge the ins, but they only had two coupling boxes.Later that day the rep.Called back and wanted someone to call the patient back because they ¿had been charging for a while and should be at 25% so they should be able to be walked through turning stimulation on.¿ the rep.Then reiterated the patient had their stitches taken out on tuesday and knew swelling could be the issue with coupling so the patient had to press the recharger against their implant quite a bit to get coupling.Following the conversation with the rep.The consumer was called back and reported the ins was still low.The consumer tried to turn stimulation on, but they saw an icon the battery needed to be charged.It was noted it was better than what they were previously seeing as it was now showing that the ins was low.It was reviewed with the consumer they should continue to charge the ins and that it needed to be at least 25% before it could be turned on.The following day the rep.And the patient called back and continued to have issues with coupling.The antenna locate feature was used with results of 60-70 for coupling one inch below the incision line.A charge session was initiated with two to six fluctuating coupling boxes so it was recommended to have the ins position checked by the doctor.On (b)(6) 2018 the rep.And patient called back with the same charging issues and the patient continuing to have difficulty charging.On (b)(6) 2018 the rep.Reported they were with the patient and their recharger wasn¿t taking a charge when it was plugged in even though it didn¿t feel loose or bent.The rep.Then used their own desktop charger with the patient¿s recharger and found it charged the recharger and thus the issue was the patient¿s desktop charger and a loose connector pin.No further complications were anticipated.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7520277
• MDR Text Key: 108983168
• Report Number: 3004209178-2018-11108
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169105492
• UDI-Public: 00643169105492
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

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: 11/14/2018
• 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: 05/14/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 05/31/2018
• Supplement Dates FDA Received: 05/30/2018; 05/31/2018
• Date Device Manufactured: 12/22/2017
• 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: 86 YR