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

Model Number 37612

Device Problems Labelling, Instructions for Use or Training Problem (1318); 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 Problems Anxiety (2328); Distress (2329); Irritability (2421)

Event Date 06/11/2010

Event Type  Injury  

Event Description

It was reported that the patient received a new rechargeable implantable neurostimulator (ins) on (b)(6) 2010.It was noted that the patient used a high voltage, high pulse width, and high rate to properly inhibit her dystonia symptoms.The first time recharging, the recharging belt was too large for the patient.Therefore, the shoulder and waist belt were shortened to fit the patient¿s body size tightly; the shoulder and waist belt had to be manually fixed to fit the patient¿s body by sewing some stickers to the belt.The patient and caregivers were then educated on how to use the recharging system.It reportedly took more than three hours for 25% ¿level charge.¿ the recharging efficiency coupling varied from 8 bars to none, which happened even when the patient remained motionless.The recharging belt was modified several times in order to keep recharging efficiency coupling at 6-8 bars.However, this could not improve the recharging time a lot.It was stated that overall, the recharging procedure was troublesome and intolerable to the patient, caregivers, and hospital.The reporter stated that the recharging issues reported by the patient did not match with what was seen in the instructional dvd and brochure.It was noted that the recharging time was quite long and the patient and caregivers could not tolerate such long recharging duration.The reporter stated that the above issues made the patient and caregivers angry, nervous panic, and stressed.The patient found the recharging procedure and recharging interval mentioned in the instructional dvd and brochure was not realistic and not what the patient had expected after viewing the dvd.It was stated that the recharging procedure was bad and the recharging interval was long; the patient had to charge up the ins ¿more frequently.¿ the ins was eventually explanted and returned to the manufacturer; the reason for explant was not clear.It was later reported that the patient was receiving effective therapy.Please note that this event was also reported in the following published literature 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) female 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 attached 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

Product id 3550-54, lot# unknown; product type accessory product id 37651, serial# (b)(4); product type recharger.(b)(4).

Event Description

Additional information received reported that the device was not explanted and the patient was still receiving effective therapy.

• 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: 4298963
• MDR Text Key: 16302619
• Report Number: 3004209178-2014-22639
• 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: Health Professional
• Type of Report: Initial,Followup
• 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?: Yes
• 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: 12/17/2014
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 00034 YR