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); Communication or Transmission Problem (2896)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171)

Event Type  malfunction  

Manufacturer Narrative

Product id 37651, serial# (b)(4); product type recharger product id 3387-40, lot# v000198, implanted: 2005 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2004 (b)(6); product type extension product id 37651, serial# (b)(4); product type recharger.(b)(4).

Event Description

A consumer reported that they did not think their recharger was working to charge the implantable neurostimulator (ins) because their tremor came back suddenly and was very bad.The patient had poor telemetry or no telemetry when recharging and they were having difficulty recharging.The patient was told to charge for 20 minutes a day and they had been doing that.After positioning the antenna over the ins, the patient was able to get 6-8 coupling bars and the ins was charging up to about a quarter full.The recharger was working normally and the patient was able to charge successfully.The ins was confirmed to be off at the time of this report, but the patient was able to turn the ins back on.Initially the patient felt an uncomfortable tingling sensation down their arm, but the sensation dissipated during the call.The patient's tremor had also gone away.The patient's indication for use is parkinson's dual and movement disorders.Troubleshooting had resolved the issue and the patient was going to follow up with their health care provider if they continued to have symptoms.

• 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: 5031373
• MDR Text Key: 24559444
• Report Number: 3004209178-2015-16733
• 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: consumer
• Reporter Occupation: Other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Date Device Manufactured: 03/11/2015
• 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: 00087 YR