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

Model Number 7426

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported there was an intermittent shocking sensation in the pocket and at various times.It was noted it happened intermittently since the therapy was initiated many years prior to report.It was stated they had tightening periodically at the skull but they were unable to give details on when and why.It was noted the issue was not resolved and the cause was not determined.It was stated the patient met with the manufacturer representative at the planned deep brain stimulator (dbs) battery replacement and possible extension revision one day prior to report.It was noted they had long-term intermittent shocking sensation at the ins pocket.It was stated the replacement was determined to not be necessary at the time of report as the patient only used the therapy intermittently at very low voltages.It was noted the replacement and extension exploration was cancelled.A pre-operative impedance measurement was taken and all was normal.The patient status at the time of report was alive with no injury.It was further reported the patient thought a smaller and thinner lead should be made and the patient programmer was too big and a small device should be designed.It was noted the extension pressed behind their ear and it would irritate their scalp.They had ¿electrical shorts¿ in their head since 2000 and as a result they would not turn the therapy on as often.It was noted the surgery was cancelled because the implant battery was bigger than their current implant.Additional information received reported nothing was planned and the patient was doing the same as when they arrived 2 days prior to report.Additional information received reported the patient did not have a 50% or greater symptom reduction and the cause of the event was not determined.It was noted reprogramming was not needed and no re-operation was performed.No troubleshooting or interventions were performed and the patient was not recovered and their symptoms and the issue were ongoing.

Event Description

Additional information received reported the patient had their left lead placement moved/revised at the end of (b)(6) 2015 and the right side was planning to be moved.

Manufacturer Narrative

Concomitant products: product id 748251, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension; product id 7426, serial # (b)(4), implanted: (b)(6) 2004, product type implantable neurostimulator; product id 748251, serial # (b)(4), implanted: (b)(6) 2004, product type extension; product id 3389-40, lot # j0337612v, implanted: (b)(6) 2004, product type lead; product id 3389-40, lot # j0537527v, implanted: (b)(6) 2005, product type lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2005, product type extension; product id neu_ptm_prog, serial # unknown, product type programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: SOLETRA
• 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: 3925139
• MDR Text Key: 4667940
• Report Number: 3004209178-2014-12771
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2006
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2015
• Date Device Manufactured: 06/28/2005
• 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: 00057 YR