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

Model Number 37612

Device Problems Break (1069); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Type  Injury  

Event Description

It was reported that there were problems recharging.It was noted that the patient had a hard time charging.It was noted that ever since implant the patient had problems charging.It was noted that the patient usually only got 4 bars and it took a lot of adjusting of her body and she had to ¿prop her boob up.¿ patient had seen the manufacturing representative last in (b)(6) 2013.It was noted that after 1.5 hours of charging the patient only got to 50% and the charge would only last about 6 hours.It was noted that the first time the implantable neurostimulator (ins) was too deep and they went back in and moved the ins and had to redo one of the leads in (b)(6) 2013.The recharger would not fully charge the implant.Anomaly appeared to have occurred through product use.There was no indication of patient harm.It was later reported coupling seemed to be the issue with the rechargeable device.It was noted that the patient would recharge for 45 minutes to an hour daily and get up to 50%.It was noted that the recharger seemed to deplete much quicker.Patient had a ¿faulty¿ electrode on the right side and had surgery to replace the lead in (b)(6) 2013.Additional information received reported the patient was still having concerns with their device or therapy but was working with their healthcare professional or manufacturing representative.It was noted that the patient had an appointment scheduled for (b)(6) 2014.

Manufacturer Narrative

Concomitant products: product id 3389s-40, lot# v944205, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type lead; product id 37751, serial# (b)(4), product type recharger.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# v944205, implanted: (b)(6) 2013, product type: lead.Product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, product type: lead.Product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type: lead.Product id 37751, serial# (b)(4), product type: recharger.(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Additional information received reported the device was difficult to charge so the healthcare professional had wanted to replace the device.The device explant occurred on (b)(6) 2014.There was a performance issue.The device was difficult to charge and had taken a long time to charge.There were no patient complications.There was a possible defective device.

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# v944205, implanted: (b)(6) 2013, product type: lead.Product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, product type: lead.Product id 3389s-40, lot# v425792, implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type: lead.Product id 37751, serial# (b)(4), product type: recharger.Analysis of the implantable neurostimulator found the device was functionally ok and anomalies were insignificant.

Event Description

Additional information received reported the first surgery had not improved the recharging so a second surgery was done.The patient was having a much easier time recharging.

Manufacturer Narrative

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

• 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: 3864325
• MDR Text Key: 14880663
• Report Number: 3004209178-2014-11308
• 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,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2014

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: 06/28/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 06/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/15/2014
• Supplement Dates FDA Received: 07/07/2014; 07/28/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2012
• 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): Required Intervention
• Patient Age: 00049 YR