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

Model Number 37612

Device Problems Delayed Charge Time (2586); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Anxiety (2328); Depression (2361); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Additional information received reported there was no change at the time of report.The patient was waiting to have their devices removed.The surgeon¿s office was waiting on paperwork from the patient before they could seek approval for the removal/replacement.Additional information received reported there was a possibility that the devices were implanted too deeply.There was a coupling problem that was reported and a communication problem.The patient had to charge too often.The patient had difficulty charging both of their implants; one wouldn¿t communicate at all and one had poor coupling.They had mentioned concerns about the ins ¿could be implanted¿ too deeply.

Event Description

It was originally reported on (b)(6) 2014 there was a coupling problem.It was noted their right side was better but they generally would get 0-2 bars on the left implant.It was noted, the patient got 8 bars at the time of report but then lost 2 at the end of the call.Two weeks later, it was reported that the patient was still having concerns regarding her device or therapy, but was working with her doctor or manufacturer representative.The patient could not find a psychiatrist near her that worked with the therapy.The patient had called the manufacturer and spoken with a representative several times.The patient¿s left implantable neurostimulator (ins) had been off ¿for weeks¿ because, it would not recharge properly.The patient wrote that she needed surgery to replace the rechargeable batteries with the regular kind again.The patient noted that they take forever to charge and had to be in the perfect spot.Six days later, it was reported that the reporter did not believe the patient had been able to see a psychiatrist.The recharging frequency matched the patient¿s settings and the patient was trained and able to demonstrate effective recharging.The patient was in continuous mode.It was determined that one ins was placed deeper than the other and it was difficult for her to get ideal coupling for the fastest recharge time.The main issue was anxiety due to the need for recharging.The patient had obsessive compulsive disorder (ocd) and was becoming obsessive about the status of her ins¿s.To the reporter¿s knowledge, the patient¿s ins¿s had not reached discharge or overdischarge.The patient received a magnet which had helped with her charging.However, the patient had great anxiety about the rechargeable ins¿s and wanted them removed.The patient was waiting for insurance approval for the removal.To the reporter¿s knowledge, the patient was receiving therapy.The reporter was going to get in touch with other psychiatrists who could manage her therapy.Ten days later, it was reported that the ins¿s had not been able to be remotely recharged full, even after four to twelve hours daily, and barely obtained a modest recharge on the right side.The left ins continued to die because of the charging problems.No movement was possible for the signals to be effective, putting the patient¿s life on hold for hours.This exacerbated the patient¿s ocd because of precision placement issues.The patient had been without an effective ins since (b)(6) 2014, increasing her ocd, hoarding, isolation tendencies, depression, eating disorders, self-medication, difficulty in making decisions, and even suicidal tendencies.These issues seemed to be caused by the inactive ins and/or lack of proper monitoring of medication.It was noted that the patient¿s insurance would not cover any more expenses.Eleven days later it was reported that the patient was awaiting approval to have her ins¿s explanted.The reporter had offered the patient two psychiatrists for follow up, but the reporter had not heard back from her.The patient¿s status was unknown.Refer to manufacturing report #3004209178-2014-12880 as the patient had two implants and the right was an issue as well.

Manufacturer Narrative

Product id 37612, serial#(b)(4), implanted: 2014 (b)(6); product type implantable neurostimulator product id 3391s-40, lot# v597842, implanted: 2012 (b)(6); product type lead product id 37651, serial# (b)(4), product type recharger product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 3391s-40, lot# v597842, implanted: 2012 (b)(6); product type lead product id 37651, serial# (b)(4); product type recharger.(b)(4).

Event Description

It was further reported an x-ray was going to be scheduled to assess the integrity of the system.Additional information received reported the patient was provided education which would decrease their recharge time.They had not heard back from the patient.

Event Description

Additional information received reported the patient was doing better with the recharging but overall they wanted to have both rechargeable ins's removed.The recharging burden was too much for her.No x-rays had been performed.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the left ins was under the muscle and in the armpit area so there was more depth than optimal but they could get 6 bars.They charged for 6-7 hours and could not get past 25%.The statistics showed the patient only charged 0.7-1.1 hours.The patient wanted their rechargeable device out and replaced with a primary cell battery.The patient was going to be seen on the day of report.There was no issue recharging the right ins, only with the left ins.The issue seemed that the patient would charge for extended periods of time but it would not show results in the charge.The implant was under muscle more so than other devices for cosmetic purposes.The patient's device was at 0%.It was further reported they were able to start charging with some education the day prior to report and they were able to get 50% on one side and 75% on the other side.The patient's symptoms were worse than they were pre-operatively.The patient had other psychological issues: addictive behavior, hoarding, self-mutilation, ocd, and an eating disorder.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the patient was not doing as well with the rechargeable battery as they were with the single channel battery.The patient had been at 8.5v in the past but got "cdw" so they were at 7v at the time of report.It was noted if the amplitude was increase they also got a euphoric feeling.They would also get a contralateral limbic smile and they became manic but that was a delayed response.They could not sleep when that would happen.

• 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: 3929006
• MDR Text Key: 4605861
• Report Number: 3004209178-2014-12881
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• 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,Followup,Followup,Followup
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Date Device Manufactured: 05/16/2013
• 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 Outcome(s): Other
• Patient Age: 00034 YR