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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 37602
Event Type  Injury  
Manufacturer Narrative

Analysis of the extension found the body of the extension (s/n (b)(4)) was cut through and the product was segmented. Analysis of the lead (lot # va0rb07) found the conductor of the lead at the proximal end was broken and there was a short between circuits (dry conditions). Conductor #0 and #1 were broken at the connector weld sites. Circuits #0 and #1 were intermittently shorted when tested at the distal end.

 
Event Description

It was reported the patient had a return of symptoms. The lead and extension had performance issues and there was an open circuit on one electrode with a possible short on other electrodes. The manufacturing representative stated the lead tip and extension connection could be the cause of the short. The lead and extension were 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.

 
Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type extension. Product id: 3389s-40, lot# va0rb07, implanted: (b)(6) 2015 explanted: (b)(6) 2015, product type lead. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2002, explanted: (b)(6) 2015, product type extension. Product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type lead. Product id: 3389s-40, lot# va0rb07 implanted: (b)(6) 2015, explanted:(b)(6) 2015, product type lead. (b)(4).

 
Event Description

Additional information received reported the patient was doing fine.

 
Manufacturer Narrative

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

 
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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 Key4781011
Report Number3004209178-2015-09341
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/14/2013
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/15/2011
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: 05/19/2015 Patient Sequence Number: 1
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