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

Model Number	SC-2218-30
Medical Device Problem Codes	Bent (1059); Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model#: sc-2218-50 serial #: (b)(4) description: linear st lead model#: sc-2218-70 serial #: (b)(4) description: linear st lead model#: sc-3138-25 serial #: (b)(4) description: scs phiii ext 25cm.
Event or Problem Description
A report was received that during a revision procedure high impedances were noted.The patient underwent a procedure wherein one extension and two leads were removed.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Additional information was received that the patient's clik anchor was damaged in the procedure and the bsn representative was not sure if the missing component was explanted.Sc-2218-70 (sn:(b)(4)): the complaint has been confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 34 cm from the proximal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed all cables were fractured at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-2218-50(sn:(b)(4)): the complaint has been confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 33 cm from the proximal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed all cables were fractured at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-3138-25(sn:(b)(4)): device evaluation indicated that the returned lead extension was analyzed and no anomalies was found.Sc-4316(lot #: (b)(4)) the clik anchor has torn eyelet with missing silicone material.
Event or Problem Description
A report was received that during a revision procedure high impedances were noted.The patient underwent a procedure wherein one extension and two leads were removed.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Additional information was received that the physician was not aware where the missing silicone was.
Event or Problem Description
A report was received that during a revision procedure high impedances were noted.The patient underwent a procedure wherein one extension and two leads were removed.The patient was doing well postoperatively.

• Brand Name: PRECISION SPECTRA®
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6309682
• Report Number: 3006630150-2017-00335
• Device Sequence Number: 16254022
• Product Code: LGW
• UDI-Device Identifier: 08714729771180
• UDI-Public: (01)08714729771180(17)140607(10)15293118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2017

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: 06/07/2014
• Device Model Number: SC-2218-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/14/2017; 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR