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

Model Number SC-2366-50

Device Problems Fracture (1260); High impedance (1291); Material Separation (1562)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2366-50, serial #: (b)(4), description: linear 3-6 lead, 50cm.Model #: sc-8216-50, serial #: (b)(4), description: artisan surgical lead, 50cm.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 medwatch will be filed.

Event Description

A report was received that the patient was not receiving stimulation.High impedances were noted on the entire lead.X-ray showed lead fracture.No further course of action will be taken at this time.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein two leads was replaced.Device malfunction was suspected with the replaced leads.The patient was doing well postoperatively.

Event Description

A report was received that the patient was not receiving stimulation.High impedances were noted on the entire lead.X-ray showed lead fracture.No further course of action will be taken at this time.

Manufacturer Narrative

Sc-2366-50 (sn (b)(4)): device evaluation indicated that the complaint of high impedance was confirmed.Visual inspection revealed lead was distal end was completely separated from the lead body, just distal of electrode #8.The distal end section of the lead was not returned.It appeared that excessive tensile force was exerted onto the lead which resulted in the separation of the distal electrodes from the rest of the lead.Electrical testing could not be performed on the returned section of the lead.Sc-2366-50 (sn (b)(4)): device evaluation indicated that the complaint of high impedance was confirmed.Visual inspection revealed lead was distal end was completely separated from the lead body, just proximal of electrode #8.The distal end section (electrodes 1-7) of the lead was not returned.It appeared that excessive tensile force was exerted onto the lead which resulted in the separation of the distal electrodes from the rest of the lead.Electrical testing could not be performed on the returned section of the lead.

Event Description

A report was received that the patient was not receiving stimulation.High impedances were noted on the entire lead.X-ray showed lead fracture.No further course of action will be taken at this time.

• 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: 5238110
• MDR Text Key: 31669694
• Report Number: 3006630150-2015-02990
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Report Date: 10/30/2015

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: 06/30/2016
• Device Model Number: SC-2366-50
• Other Device ID Number: M365SC2366500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2015; 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2014
• 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: 42 YR