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)

Patient Problems Tingling (2171); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Type  malfunction  

Event Description

It was reported the patient had a loss of stimulation.The stimulation had been turned off in 4 different situations.The first was in (b)(6) 2014 during dinner time when the patient ¿felt weird¿.The implantable neurostimulator recharger (insr) was checked and the insr confirmed the device had battery life but the stimulator was turned off.The second situation was in (b)(6) 2015 and it happened in the middle of the night.They had confirmed the stimulation had been turned off by the recharger.The third situation was on (b)(6) 2015.Towards the evening hours the patient did not feel well, they had difficulty swallowing and speaking.They confirmed the therapy was off by the patient programmer.They had pressed the orange check button and then pressed the gray button to turn the stimulation back on.The fourth situation was the day after and they felt tingling on their face, could not speak, and had trouble swallowing.The patient¿s hands and feet were curling and it was difficult to catch her breath.They had placed the insr on the patient at 2:28pm and by 4:20pm they confirmed the stimulation was turned off.The beginning battery was 50% and they were getting 6-8 coupling bars.When using the recharger, they did not get the antenna locate (al) screen.The recharger would make a lot of clicking sounds every 2 minutes but would continue to get 6-8 coupling bars.The patient was now charging about 3 hours to get the device full.When the device was at 75% full it would be drained to 25% by the next morning.It was noted it was a gradual change in symptoms.Additional information received reported the physician thought the battery was getting recharged so frequently that the implantable neurostimulator (ins) was dying prematurely.Impedance measurements were taken and there were no electrodes out of range.The implant was on and there were no emi exposures.The patient experienced symptoms when the ins was off but they were not related to positional movement.The patient had a sudden return of symptoms.The patient had dystonia.All occurrences were noted to happen during or after recharging.A longevity calculation was performed which showed the ins would be at a low (25%) charge after 3.47 days and would be empty (0%) at 4.63 days with the patient¿s current settings.Additional information received 4 days later reported the analysis of the data from the external charging device was communicated to the physician verbally on (b)(6) 2015.The described device issue had been resolved.The cause of the problem was the patient wasn¿t charging the device properly.The patient would let the device go to 0% charge.The physician planned to meet with the patient¿s family and discuss their options.The device was proven through data analysis to be working properly but the patient was not charging appropriately.

Manufacturer Narrative

Concomitant medical products: product id 37651, serial# (b)(4), product type: recharger.Product id 3387s-40, lot# v821660, implanted: (b)(6) 2012, product type: lead.Product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id 37601, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id 3387s-40, lot# v821660, implanted: (b)(6) 2012, product type: lead.Product id 37642, serial# (b)(4), product type: programmer, patient.Product id 37651, serial# (b)(4), product type: recharger.Product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.(b)(4).

Manufacturer Narrative

(b)(4).

• 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 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: 4932027
• MDR Text Key: 6034904
• Report Number: 3004209178-2015-13860
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/06/2015

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: 01/28/2015
• 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: 07/06/2015
• Initial Date FDA Received: 07/22/2015
• Date Device Manufactured: 03/05/2014
• 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