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

Model Number	SC-2366-30
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2366-30 serial #: (b)(4) description: linear 3-6 lead, 30cm model #: sc-2366-50 serial #: (b)(4), 394749 description: linear 3-6 lead, 50cm model #: sc-3354-25 serial #: (b)(4) description: w4 splitter 2x4-25 cm the explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that three of the four leads implanted in the patient displayed high impedance readings.The patient underwent a revision procedure wherein all of the leads and lead splitters were replaced.The physician suspected device malfunction.The patient is doing well post-operatively.

• 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: 6942915
• Report Number: 3006630150-2017-04079
• Device Sequence Number: 19039524
• Product Code: LGW
• UDI-Device Identifier: 08714729789659
• UDI-Public: 08714729789659
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2017

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: 10/20/2013
• Device Model Number: SC-2366-30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1