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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 Type  Injury  
Event Description

It was reported that starting sunday prior to the date of this report that patient felt like the device had a shot circuit but had not heard anything. It felt like buzzing intermittently in the patient¿s head and he got dizzy. Therapy had been good besides that and nothing had specifically set it off that the patient remembered. The patient had stopped taking his depression medications prior to halloween. There were no falls or traumas noted. Impedances were: 0 and 1 ¿ 50 ohms and c,0 and c,1 were normal. Impedances were first noted at the patient¿s last programming session on (b)(6) 2014 along with the 273 drain. The patient was programmed with +2-1-0, 2. 0v, 60pw, 185 rate and 900 ohms. A longevity estimate calculation was done and showed 79 months or 6. 58 years. Battery voltage was 3. 74v. The patient had elected to have the battery changed and impedances would be checked intra-operatively, they would change the extension if it was still showing a short. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

 
Event Description

Additional information received reported that the patient had their left stimulator replaced on the date of this report. This had not corrected the short circuit between electrodes 0 and 1. The surgeon had then replaced the extension and the impedances had come to a normal range.

 
Manufacturer Narrative

Concomitant medical products: product id 7426, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 3389-40, lot# j0104134v, implanted: (b)(6) 2001, product type: lead; product id 7495-51, serial# (b)(4), implanted: (b)(6) 2001, product type: extension; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3387s-40, lot# v227370, implanted: (b)(6) 2009, product type: lead. (b)(4).

 
Manufacturer Narrative

 
Manufacturer Narrative

 
Event Description

Additional information received reported that surgical intervention was planned, but nothing had been scheduled.

 
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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 Key4291732
Report Number3004209178-2014-22406
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/11/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/02/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2010
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/15/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/19/2009
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: 12/02/2014 Patient Sequence Number: 1
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