MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7426

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

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

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins) for parkinson's disease.It was reported that when a telemetry of stimulation parameter was performed, it was found the polarity had autonomously changed.The patient had been programmed to 2-, case during previous visit, but had autonomously changed to 0-, 2+.The patient was set to 2v, 90 us, 145 hz/pps.Impedances were >2000 ohms on electrode pairs 0 & c, 0 & 1, 0 & 2, and 0 & 3.The ins was scheduled to be replaced in the near future, a close inspection of the ins after removal was requested by the hcp.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturing representative (rep) indicated both side inss were replaced due to depletion.Preoperatively, impedance measurement of both sides was performed; the impedance was normal, despite several impedances >2000 ohms.After that, at the time when the patient's positioning was done, stimulation of both the side inss were turned off by a medical engineer.At that time, when stimulation was turned off, the output setting and the rate both of only the left side ins autonomously changed; the output setting changed from 2.0v to 2.2v, the rate changed from 45hz to 30hz.The replacement procedure was continued because it was originally scheduled.A close inspection to determine the cause of the events, including the one previously reported, had been requested.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturing representative (rep) that an electrode fracture was typically presumed when the impedance was over 2000 ohms and the current was under 7 a at the same time.In this situation, while contact #0 showed >2000 ohms, the current was 9 or 10 a, so the hcp determined this case was a little higher impedance and not a fracture.The doctor did not consider this case an issue.

Manufacturer Narrative

Analysis of the ins (serial no.(b)(4)) found no significant anomaly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7538946
• MDR Text Key: 109111988
• Report Number: 3007566237-2018-01541
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2018

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: 09/14/2011
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 05/23/2018; 06/12/2018; 09/20/2018
• Supplement Dates FDA Received: 06/05/2018; 06/26/2018; 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2010
• 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