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

Model Number 37612

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 03/09/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37791, serial# unknown, product type: recharger.Product id: 3389-28, lot# unknown, implanted: (b)(6) 2012, product type: lead.Product id: 3708660, serial# unknown, implanted: (b)(6) 2012, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37651, serial# (b)(4), product type: recharger.

Event Description

It was reported that the patient began having troubles recharging the week prior to the report.She used to charge for a half hour to an hour and her battery level would show 100%; she regularly "topped off" her implantable neurostimulator (ins).Now she tried to charge for an hour or more and the battery did not seem to be taking a charge; it would only show a battery level of 75%.The patient was charging more than expected and had to charge longer, because her coupling boxes jump from 2 to 8 even when the antenna was stationary.There was no event that preceded these charging changes.The physician's assistant (pa) wanted to start by changing out the antenna; the external antenna was broken.No device returned.C500.Follow-up information received from the healthcare provider (hcp) reported that the recharging frequency did not match the patient's settings.She was on continuous mode and the event was found to be device related.She was able to demonstrate effective recharging.The patient brought the recharger to her appointment and the efficiency bar never reached 8 bars.For the most part it was at 6 bars and quickly dropped to 4 bars despite adjusting the antenna.She was receiving effective therapy, but it took two times the amount of time to charge the ins.All of the electrode impedances were found to be in normal range.The ins was adjusted, but this was to avoid side effects and was unrelated to the recharger unit issues.The patient recovered without permanent impairment and she would be sent a new antenna.A healthcare professional reported the patient whose indication for use was dystonia and movement disorders was charging too often and it was different than before.The patient charged every morning and by midday it was down to 50% and it was noted that the patient had believed that the same charge use to last about 1.5 days.No programming changes have been made.Therapy impedance was checked.Patient settings on the left were 5.0v, 120usec, 160hz, 1499 ohms and on the right were 4.5v, 120usec, 160hz and 1553 ohms.Recharge interval was 100-0% at about 14 days.Clinician programmer recharger stats indicated an average coupling of 8 boxes and the following charges were seen on (b)(6) charged for 1.3 hours to 75%, (b)(6) charged for 1.1 hours to 75%, (b)(6) charged for 1.2 hours to 75%, (b)(6) charged for 2.1 hours to 75%, (b)(6) charged for 1.5 hours to 100% and (b)(6) charged for 1.4 hours to 75%.The patient does not turn the implantable neurostimulator (ins) off.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5615707
• MDR Text Key: 43992022
• Report Number: 3004209178-2016-08474
• 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,Followup
• Report Date: 04/28/2016

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: 10/28/2014
• 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: 03/16/2015
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: 03/16/2015
• Supplement Dates FDA Received: 09/21/2017
• Date Device Manufactured: 12/12/2013
• 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: 57 YR