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

Model Number 37612

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); No Device Output (1435)

Patient Problem Seizures (2063)

Event Type  Injury  

Event Description

It was initially reported that the patient¿s programmer component of their implantable neurostimulator (ins) malfunctioned last week and was working with their healthcare professional (hcp) to obtain a replacement unit (device was at the hcp¿s office).It was also reported that the ins will not turn on using the top button on the side of the recharger unit.A power-on-reset (por) condition on the ins was suspected thought the patient did not report one.The patient could only see the ¿charge complete¿ screen on the recharger and ¿nothing else¿.Additional information received a day later reported that the ins battery in the patient¿s chest was not charging when using the recharger unit.The recharger unit was not working properly and was to be replaced for the patient.Further information received from the patient on (b)(6) 2013 reported that they were able to recharger the ins but was unaware as to how to turn it back on.It was confirmed that the patient¿s programmer unit was at their doctor¿s office and that the batteries had died.The patient stated that they were not supposed to turn of the stimulation from the ins but ¿somehow it turned itself off¿.The patient was able to turn the turn on the stimulation via the recharger unit.It was also reported that the recharger unit ¿failed¿ and did not allow the patient to charge.The last time the patient was able to fully charge was about 4 days ago.The patient could not remember if they had a por condition on their ins or not.The patient reported that the ins was helping with their symptoms but that they did have a seizure.Follow up information received on (b)(6) 2013 confirmed that the patient was sent a new recharger (b)(4) overnight.It was noted that there no further complaints had been received from the hcp¿s office or the patient.It was also believed that the patient was confusing the patient programmer unit with the clinician programmer unit.It was also noted that the programmer unit may have been lost in a fire at the patient¿s home.The patient was given a new programmer at that time and was instructed on its use.In addition, it was reported that there was no evidence that a por condition had occurred on the patient¿s ins device.It was also confirmed that the patient did experience one seizure on (b)(6) 2013 and it was unable to be determined if was due to the recharging difficulties, programming, or was their normal seizure activity.The patient was also re-trained in (b)(6) 2012 for the issue of the having difficulty recharging the device although it was noted that there was a possible failure of the recharger unit.Additional information received on (b)(6) 2013 reported that when the patient pressed the ¿button¿ the stimulation did not turn on.It was noted that the on/off buttons on the recharger were ¿not working¿.In addition, it was reported that the patient had given the programmer unit to the hospital because it would ¿not respond¿.No ¿pictures¿ would come up on the screen event when the patient tried new batteries and troubleshooting.It was also reported that the last time they recharged the ins was 3 or 4 days ago.It was noted that the recharger was charging in the first quadrant.The patient stated that they were part of an experiment for the manufacturer and that they were ¿the only person in the united states with leads in his frontal lobe and a rechargeable ins in his chest¿.The patient reported that the still did not receive a programmer though it was noted that one was sent to them.It was then reported that the programmer unit ¿would not do anything¿, would not turn on or off, and was ¿just blank¿.The antenna locator feature was used tried one more time to ¿activate the stim on/off buttons¿ and the ins was able to be turned on as a result.Information received on (b)(6) 2013 reported that the ¿technical observation¿ revealed that the recharger device was not functioning and that a new one was sent to the patient.The event outcome was reported, as of (b)(6) 2013, as resolved without sequelae.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Product id 3387-40, lot# j0417731v, implanted: 2004 (b)(6); product type lead product id 3387-40, lot# j0417731v, implanted: 2004 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2004 (b)(6); product type extension product id 748251, serial# (b)(4), implanted: 2004 (b)(6); product type extension product id neu_unknown_prog, serial# unknown; product type programmer, physician product id 37651, serial# (b)(4); product type recharger.(b)(4).This device was being used in a clinical trial for the treatment of adult refractory epilepsy.

• 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: 3645898
• MDR Text Key: 16057311
• Report Number: 3004209178-2014-03575
• Device Sequence Number: 1
• Product Code: MHY
• 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: Study,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2013

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: 10/14/2010
• 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: 03/20/2013
• Initial Date FDA Received: 02/25/2014
• Date Device Manufactured: 11/20/2009
• 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: 00060 YR