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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
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.

 
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Brand NameSOLETRA
Type of DeviceSTIMULATOR, 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 Key4925503
Report Number3004209178-2015-13680
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
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 Received07/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2011
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/20/2015 Patient Sequence Number: 1
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