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

Model Number	SC-4108
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model # sc-5132 serial # (b)(4) description: precision spectra external trial stimulator model # sc-3138-55 serial # (b)(4) and 20232525 description: scs phiii ext 55cm.
Event or Problem Description
A report was received that the trial patient felt a high burning sensation on the lead extension and the external trial stimulator (ets), and they felt hot.It was noted that the ets was inside the patient¿s belt.The patient immediately turned the stimulation off.It was reported that the or cable had a black mark on one of the extensions similar to a scorch.
Additional Manufacturer Narrative
Additional was received: ets model # sc-5132z model # sc-3138-55 serial # (b)(4) lot# 19991387 description: scs phiii ext 55cm model # sc-3138-55 serial # (b)(4) lot # 20232525 description: scs phiii ext 55cm ipg sc-5132 sn (b)(4): since the associated leads were missing distal tips, the ets was investigated with known good test leads.Impedance measurements were within the expected range.The monitored stimulation on an oscilloscope found that the outputs were consistent and amplitude/pulse widths were verified to be correct on all the electrodes.The ets passed all the required tests performed and revealed no anomalies.Sc-3138-55 sn (b)(4) the distal tip was cut off and missing.X-ray inspection on the remaining lead body found no cable breakage.Damage to the device was similar to the typical explant damage and was not considered a failure.Or cable sc-4108 lot# 20284149 ((b)(4)): the device passed all required tests performed and revealed no anomalies.
Event or Problem Description
A report was received that the trial patient felt a high burning sensation on the lead extension and the external trial stimulator (ets), and they felt hot.It was noted that the ets was inside the patient¿s belt.The patient immediately turned the stimulation off.It was reported that the or cable had a black mark on one of the extensions similar to a scorch.
Additional Manufacturer Narrative
Sc-3138-55, sn (b)(4): the lead extensions were analyzed and the complaint of the lead extension being scorched was not confirmed.The distal tip was cut off and missing.Visual inspection did not reveal any burn marks.X-ray inspection on the remaining lead body found no cable breakage.Damage to the device was similar to the typical explant damage and was not considered a failure.
Event or Problem Description
A report was received that the trial patient felt a high burning sensation on the lead extension and the external trial stimulator (ets), and they felt hot.It was noted that the ets was inside the patient¿s belt.The patient immediately turned the stimulation off.It was reported that the or cable had a black mark on one of the extensions similar to a scorch.

• 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: 6539156
• Report Number: 3006630150-2017-01669
• Device Sequence Number: 119267
• Product Code: LGW
• UDI-Device Identifier: 08714729821533
• UDI-Public: (01)08714729821533(17)190214(10)20284149
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/14/2019
• Device Model Number: SC-4108
• Device Lot Number: 20284149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided; 07/11/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 06/20/2017; 07/24/2017
• 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