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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION
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BOSTON SCIENTIFIC NEUROMODULATION Back to Search Results
Device Problem High impedance (1291)
Patient Problems Discomfort (2330); No Code Available (3191)
Event Date 11/16/2018
Event Type  Injury  
Manufacturer Narrative
It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The model and serial number of the device is not known, therefore a device history review cannot be performed.
 
Event Description
A report was received that the patient underwent a lead revision procedure due to feeling discomfort when he moves his head down.The physician stated that the lead has high impedance on contact 3, and it was not used in the patients programs.The patient is doing well post-operatively.
 
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Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key8151714
MDR Text Key130024614
Report Number3006630150-2018-62188
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/11/2018
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2018
Initial Date FDA Received12/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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