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

Model Number	SC-3138-25
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The explanted devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.Additional suspect medical device component involved in the event: model #: sc-3138, serial #: (b)(4), description: scs phiii ext 25cm.
Event or Problem Description
A report was received that the patient could not get adequate coverage and has no pain relief.It was noted that the leads showed high impedances during reprogramming.The patient underwent a revision procedure.During the revision procedure, it was determined that it was the lead extensions where causing the leads to showed high impedances.The patient's lead extensions were replaced.No device malfunction was suspected.The patient was able to get the stimulation back and 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: 7645447
• Report Number: 3006630150-2018-02186
• Device Sequence Number: 1556225
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: 08714729760542
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 02/10/2018
• Device Model Number: SC-3138-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR