MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; SPINAL CORD STIMULATOR

Model Number	SC-3400-30
Medical Device Problem Codes	High impedance (1291); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit, 30 cm.
Event or Problem Description
A report was received that the products were returned as these were defective.It was noted that the contacts were out.
Additional Manufacturer Narrative
Sc-3400-30 (sn:(b)(4)) device evaluation indicated that the complaint was not verified.The device passed an impedance measurement test.However, visual inspection revealed that the lead body was bent between the contact #16 and the retention sleeve, and the contact #10 and #11.The damage was considered a procedure-related damage.
Event or Problem Description
A report was received that the products were returned as these were defective.It was noted that the contacts were out.
Additional Manufacturer Narrative
Sc-3400-30(sn:(b)(4)) device evaluation indicated that the device passed all tests performed.
Event or Problem Description
A report was received that the products were returned as these were defective.It was noted that the contacts were out.

• Brand Name: PRECISION®
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6233796
• Report Number: 3006630150-2017-00058
• Device Sequence Number: 1057276
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: (01)08714729797838(17)180830(10)19645396
• Combination Product (Y/N): N
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/30/2018
• Device Model Number: SC-3400-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/02/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 01/27/2017; 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1