MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-3400-30
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-3400-30, serial number: (b)(4), batch/lot number: 15658262, model/catalog description: splitter 2x8 kit-sterile.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 there were high impedances noted in the patient's scs system.The patient underwent a revision procedure wherein the splitters were replaced.There were still high impedances, however, all pain areas were covered.The patient was doing well postoperatively.

• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8440856
• Report Number: 3006630150-2019-01237
• Device Sequence Number: 354992
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: 08714729797838
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

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 Date: 11/01/2014
• Device Model Number: SC-3400-30
• Device Catalogue Number: SC-3400-30
• Device Lot Number: 15658262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR