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

Model Number 7426

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); High impedance (1291); Energy Output Problem (1431)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare professional via the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins) for parkinson¿s disease.It was reported that when the right ins was interrogated (had bilateral devices) on (b)(6) 2017 and was at 3.6.It was noted that the ins was in the abdomen and goes to the right brain.It was noted that the impedances were >2000 ohms on all connections.The patient felt ¿it comes off and on all the time¿.The right ins programming was done on the right subthalamic nucleus (stn) only, helping their mild tremoron the left side.Additional follow up programming was also performed on (b)(6) 2016, (b)(6) 2017, and (b)(6) 2017.Further, it was reported that on battery was replaced the week prior to (b)(6) 2017.Relevant medical history included parkinson¿s disease, idiopathic peripheral neuropathy, arachnoiditis, left foot drop which was related to the l5 radiculopathy.The patient also had a pump for pain.There were no further complications reported or anticipated.

Manufacturer Narrative

Additional concomitant medical products: product id 7426, (b)(4), product type implantable neurostimulator.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) ((b)(4)) revealed that the battery was functioning okay with insignificant anomaly¿s.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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7122364
• MDR Text Key: 95007073
• Report Number: 3004209178-2017-26098
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2010
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2009
• 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