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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MULTIWAVE; SPINAL CORD STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION PRECISION MULTIWAVE; SPINAL CORD STIMULATOR Back to Search Results
Model Number SC-1112
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 09/06/2017
Type of Reportable Event Serious Injury
Event or Problem Description
A report was received that the patient underwent an ipg replacement procedure due to inadequate pain relief.
 
Additional Manufacturer Narrative
A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
 
Event or Problem Description
A report was received that the patient underwent an ipg replacement procedure due to inadequate pain relief.
 
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Brand Name
PRECISION MULTIWAVE
Common Device Name
SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key7067713
Report Number3006630150-2017-04986
Device Sequence Number16168587
Product Code LGW
UDI-Device Identifier08714729837138
UDI-Public08714729837138
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
030017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/11/2018
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
Operator of Device Lay User/Patient
Device Expiration Date09/30/2017
Device Model NumberSC-1112
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/10/2017
Supplement Date Received by Manufacturer01/05/2018
Initial Report FDA Received Date11/29/2017
Supplement Report FDA Received Date01/11/2018
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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