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

Model Number 37612

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 37752, serial# (b)(4), product type: recharger.Product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id 37085-60, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2007, product type: lead.Product id neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2006, product type: lead.(b)(4).

Event Description

Information was received from the manufacturer representative that reported there was a 573 error code.The message had occurred twice and the patient replaced the batteries in the patient programmer (pp) and the issue was resolved.The patient was not getting the battery charged to the sprites.They felt the battery wasn't holding a charge like it used to.The patient was implanted for dystonia.Additional information received 5 days later reported the device was charging adequately despite the fact that her cervical collar was hindering her ability to position the recharge antenna in its most efficient position.No other interventions were planned.Additional information received from the patient 4 days later reported the patient was admitted to the hospital due to a fall she had which resulted in several knots on her head.Due to the fall, the patient "came to enough" to realize the implantable neurostimulator (ins) battery had depleted and she needed to recharge.Due to the battery depletion, the therapy shut itself off.They were able to recharge the ins to 25% but could not turn the stimulation on because she didn't have the patient programmer.The ins battery level was still too low to use the implantable neurostimulator recharger (insr) to turn the stimulation on.They weren't able to turn the stimulation back on yet.The patient was advised to charge to 50% and then attempt to turn the ins on using the insr.Additional information received 3 days later from the patient reported there was a 376 insr antenna temperature failure code.There was also a 375 error code (charge current low) on the recharger.There was a damaged recharging antenna.The patient's ins was charged to 50% but the ins had died so her stimulation was still off.The patient was "out of it" for a couple of days but was not unconscious since the fall.Patient was only getting 2-4 coupling boxes but they weren't trying to charge during the call.They were unsuccessful in trying to turn the ins on with the insr.She was having trouble with her hands but it had nothing to do with the dystonia.They were able to turn the ins on.

• 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: 5192260
• MDR Text Key: 30010098
• Report Number: 3004209178-2015-21926
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2010
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2015
• Date Device Manufactured: 10/20/2009
• 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): Hospitalization
• Patient Age: 00071 YR