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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the first time the patient attempted to recharge, the recharging belt was too large.The shoulder and waist belt were shortened and some stickers were sewn to the belt to fit the patient tightly.The patient was then educated on recharging.The patient went home to attempt recharging himself.However, recharging efficiency was not stable and the coupling bars could vary from 8 to 0.It was noted that even a little posture movement or chest movement during breathing could cause coupling bars to drop from 8 bars to none.The patient had to sit still without any movement during recharging.In order to improve the recharging efficiency, a pressure garment (pg) (with a pocket was sewed on to hold the recharging antenna) was tailor-made for the patient.When recharging, the patient had to take off all clothing and only wear the pg garment.The patient had to lie down without any movement during the recharging process.The reporter stated that with both the original recharging belt and pg garment, the activities of the patient were greatly limited.This issue made the patient dissatisfied and increased the workload for the doctors and nurses.It was later reported that no further troubleshooting was done and the device was not explanted.It was noted that the recharger was not replaced as the issue did not resolved with another recharger.Frequent follow-up with the patient was done to monitor the efficiency of recharging.The reporter later stated that the patient did not use the original recharging belt anymore, but used the pg garment to minimize change of antenna movement.It was stated that this improved the recharging procedure, but the problem of unstable coupling signals was still there and the patient still needed to sit without movement.It was noted that the dropped recharging coupling intervals affected recharging duration and the patient needed to adjust the recharging belt and antenna frequently.Review of the recharging statistic information showed that the patient was not charging up to 100% of the battery¿s capacity and would not let the ins get below 75% capacity.It was noted that this meant the battery¿s full capacity was not being used.It was also noted that the patient¿s recharge statistics showed some extremely variable recharge intervals.Reportedly, the ins was only being allowed to deplete in very small amounts, only down to 3.920 or 4.070 between sessions.It was noted that there were three recharge sessions which only lasted around 4 minutes and only charged the ins about 0.005v each session; the next three sessions lasted around an hour and the ins was then charged from 75% to almost full.It was later reported that no the patient was receiving effective therapy.Please note that this event was discussed in the following article: chan, d.T.M., zhu, x.L., lau, c.K.Y., wong, r.K.M., poon, w.S.Replacement of a deep brain stimulation implantable pulse generator with a rechargeable device.Surgical practice.2014;18(3):140-142.Doi:10.1111/1744-1633.12067 summary: in the present study, we report on the technical hiccups encountered while replacing the implantable pulse generator (ipg) for deep brain stimulation with a new rechargeable device.Two dystonia patients suffered from inefficient recharging after replacement of the ipg to the rechargeable device.After identifying the problem, we employed a surgical technique on the third patient.The problem was the small size of the new device.The device had a freedom-of-transverse translation and a rocking movement inside the pocket.This unstable positioning lengthened the recharging time in these two patients.By fixing the device on to the adaptor and obliterating the lateral space, the third patient encountered no recharging problems.Based on the findings of this study, ipg should be fixed on a flat subcutaneous plane and obliterate the lateral space to avoid the problem.Reported event from article: (b)(6) male dystonia patient experienced a problematic and prolonged recharging process within two weeks after replacement of their primary cell devices with rechargeable devices.The reporter stated that the patient did not suffer from any clinical symptoms, but complained of the long recharging time of hours to complete the recharge.It was noted that there was no circuitry problem reported and the impedance check showed no connection fault.Patient reported that postural variations affected the recharge efficiency, indicated in the display of the recharger.The reporter stated that the device was palpated and examined through the chest wall and it was found that the device had a freedom-of-transverse translation.It was noted that the problem was the small size of the new device and it moved around inside the pocket, which housed the device.It was noted that this unstable positioning lengthened the recharging time in the patient.Please note that the events in the literature article was previously reported in manufacturing report # 3007566237-2014-02583.Going forward, any additional information received pertaining to this event will be reported under this new manufacturing number due to the specific device and patient information that was recently received.

Manufacturer Narrative

Concomitant medical products: product id: 3550-54, lot# unknown, product type: accessory.Product id: 37651, serial# (b)(4), product type: recharger.Product id: neu_ins_stimulator, serial# unknown ,implanted: (b)(6) 2008, product type: implantable neurostimulator.Product id: 37651, serial# (b)(4), product type: recharger.Product id: neu_ins_stimulator, serial# unknown, implanted: (b)(6) 2008, product type: implantable neurostimulator.(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: 4295329
• MDR Text Key: 17585968
• Report Number: 3004209178-2014-22529
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/03/2014
• Date Device Manufactured: 03/11/2010
• 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: 00017 YR