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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37612
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(6) nkn052270v, implanted: (b)(6) 2013, product type: extension. Product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va06gxl, implanted: (b)(6) 2013, product type: lead. (b)(4).

 
Event Description

A consumer reported that they got sick between the lead implant and implantable neurostimulator (ins) implant surgeries and they were in the hospital for 4-5 days. After the patient was implanted with the leads they noticed some issues with the patient's speech and walking, which were slowly going away. The patient's speech had been worse since implant. The patient's health care provider (hcp) checked them and they did not have a stroke. The hcp concluded that the issue may be from swelling. When the ins was turned on, they did not notice the ins much, but they were noticing some of their symptoms coming back. A manufacturing representative told the patient that they could turn the ins off when needed if their speech was bad. No outcome was reported regarding this event. If additional information is received, a follow up report will be sent.

 
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Brand NameACTIVA
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 Key4991318
Report Number3004209178-2015-15776
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 07/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2013
Device MODEL Number37612
Device Catalogue Number37612
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 Received07/16/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/26/2012
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: 08/11/2015 Patient Sequence Number: 1
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