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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 37612
Device Problems Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0v7nm, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0tkv5, implanted: (b)(6) 2015, 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) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).
 
Event Description
The manufacturer representative (rep) reported that the patient was having difficulty charging and got two coupling boxes.An antenna locate had not been attempted yet, so the rep would try this with the patient.The rep also noted that the patient was thin and she could feel the implantable neurostimulator (ins) and suspected she could feel the wires on top of the ins.The pocket did not appear deep or the ins tilted.However, no x-ray had been performed to check.There were no associated symptoms.On (b)(6) 2015 the rep further reported that the patient got a maximum of two bars in coupling.They reportedly used the metal detector and it was still no better.The doctor ordered and x-ray of the ins and it showed the ins had flipped.The patient would be scheduled for surgery to flip the ins back.The patient's indications for use were parkinson's dual and movement disorders.No patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, 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 Key5024688
MDR Text Key23826272
Report Number3004209178-2015-16546
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Report Date 07/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2016
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/24/2015
Date Device Manufactured06/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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