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

Model Number 7426

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 02/11/2011

Event Type  Injury  

Event Description

It was reported the patient had a shocking sensation, intermittent/erratic therapy, and pain around the implant area.The issue started suddenly five weeks prior to this report and had gradually been getting worse.The patient saw their healthcare professional on (b)(6) 2015 and the hcp said they had a short in the batteries and there was some kind of impediment coming from the batteries.The hcp wanted to replace the implantable neurostimulators (ins).When stimulation was turned off, the patient had tremor which they had not had for 15 years.When stimulation was turned on, the patient still had tremor, but it was sporadic and it went off on and on.Every time the patient turned the ins on, they were shocked.The patient stated they were disabled and had a hard time living.The patient was working to have the inss replaced.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.Refer to manufacturer report #3004209178-2015-13679.

Manufacturer Narrative

Concomitant medical products: product id: 7426, lot# serial# (b)(4) implanted: (b)(6) 2011, product type: implantable neurostimulator, product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2011 product type: extension.Product id: 3387-40, lot# l78076, implanted: (b)(6) 2000, product type: lead.Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2000, product type: extension.Product id: 7482a40, serial# (b)(4) implanted: (b)(6) 2010, product type: extension.Product id: 3387s-40, lot# v488644, implanted: (b)(6) 2010, product type: lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 7426, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id 3387-40, lot# l78076, implanted: (b)(6) 2000, product type: lead.Product id 7495-51, serial# (b)(4), implanted: (b)(6) 2000, explanted: (b)(6) 2011, product type: extension.Product id 7482a40, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id 3387s-40, lot# v488644, implanted: (b)(6) 2010, product type: lead.(b)(4).

Event Description

Additional information was received from a patient via a manufacturer representative(rep).It was reported that the implantable neurostimulator (ins) and extension were replaced on (b)(6) 2011 and the issue was resolved.If additional information is received, a follow-up report will be submitted.Please see report numbers 3004209178-2015-13679.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Follow up information received from the patient reported that on (b)(6) 2015 the battery was replaced due to shocking.

• 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: 4925503
• MDR Text Key: 6435395
• Report Number: 3004209178-2015-13680
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2011
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Date Device Manufactured: 06/01/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR