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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-2201-30DC
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that the patient underwent a lead replacement procedure.The lead was not in the desired target area and the physician decided to explant the existing lead and implant a new lead.The current location of the explanted lead is not known.
 
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Brand Name
NA
Common Device Name
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11019637
Report Number3006630150-2020-06224
Device Sequence Number14124133
Product Code MHY
UDI-Device Identifier08714729836490
UDI-Public08714729836490
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
P150031
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/16/2020
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
Operator of Device Lay User/Patient
Device Expiration Date10/25/2021
Device Model NumberDB-2201-30DC
Device Catalogue NumberDB-2201-30DC
Device Lot Number5180882
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/07/2020
Initial Report FDA Received Date12/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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