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

Model Number SC-2317-50

Device Problems Fracture (1260); High impedance (1291); Kinked (1339); Component Missing (2306)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2317-50 serial #: (b)(4) description: infinion cx 50 cm lead.

Event Description

A report was received that the leads of the patient were broken.It was reported that fourteen (14) out of thirty-two (32) contacts were registering high during an impedance check.It was also mentioned that patient could not feel stimulation on several programs.The patient will undergo a lead replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a lead replacement procedure.The patient was doing well postoperatively.Additional suspect medical device component involved in the event: model #: sc-2317-50 serial #: (b)(4) description: infiniontm cx 50 cm lead.

Event Description

A report was received that the leads of the patient were broken.It was reported that fourteen (14) out of thirty-two (32) contacts were registering high during an impedance check.It was also mentioned that patient could not feel stimulation on several programs.The patient will undergo a lead replacement procedure.

Manufacturer Narrative

Additional information was received that the scar tissue was removed during leads removal and it was assumed that the eyelets were in the scar tissue that was explanted.

Event Description

A report was received that the leads of the patient were broken.It was reported that fourteen (14) out of thirty-two (32) contacts were registering high during an impedance check.It was also mentioned that patient could not feel stimulation on several programs.The patient will undergo a lead replacement procedure.

Manufacturer Narrative

Sc-1132 (b)(4): device evaluation indicated that the ipg passed all tests performed.Sc-2317-50 (b)(4): device evaluation indicated that the leads complaints were confirmed.Visual and x-ray inspection confirmed cable fractures on the lead bodies at the kinked sections of the leads where the clik x anchors were positioned, which resulted in high impedances.No cables were exposed at the site.In addition, the lead bodies were cleanly cut into pieces during explant procedure.Sc-4318 (ln 18338771): device evaluation indicated that the clik anchor silicone materials from the eyelets were missing.

Event Description

A report was received that the leads of the patient were broken.It was reported that fourteen (14) out of thirty-two (32) contacts were registering high during an impedance check.It was also mentioned that patient could not feel stimulation on several programs.The patient will undergo a lead replacement procedure.

• Brand Name: PRECISION SPECTRA
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6941055
• MDR Text Key: 89178424
• Report Number: 3006630150-2017-03890
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: 08714729861614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/23/2017
• Device Model Number: SC-2317-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 10/20/2017; 11/17/2017; 12/07/2017
• Supplement Dates FDA Received: 11/08/2017; 12/05/2017; 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR