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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
Device Problem Impedance Problem
Event Date 02/01/2015
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0p59t, implanted:(b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4) ,implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted:(b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

 
Event Description

A manufacturing representative reported that about a month after implant, electrodes 1 and 3 had a short and the patient's tremor had returned. The patient's indication for use is parkinson's dual and movement disorders. Impedances were measured to be fine after implant. About six weeks after implant, the short had resolved and the manufacturing representative was able to program those electrodes again so the patient received efficacy. On the day of this report, the manufacturing representative was meeting with the patient and the short had returned. A revision was done to replace the extension and the implantable neurostimulator (ins) due to the short draining the battery. The initial problem started after the patient had a fall. After the surgery, impedances were checked and they looked good. The low impedances had increased by 600 ohms. The manufacturing representative planned to meet with the patient tomorrow to program the ins. Following the revision the patient had recovered without sequela.

 
Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (s/n (b)(4)) found insignificant anomalies; the ins was functionally ok. Analysis of the extension (s/n (b)(4)) found insignificant anomalies; the molded rubber on the distal end was cut.

 
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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
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 Key5004325
Report Number3004209178-2015-16045
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2016
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/02/2014
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: 08/14/2015 Patient Sequence Number: 1
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