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

Model Number SC-2316-50

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problems Inadequate Pain Relief (2388); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: (b)(6) 2014.Additional suspect medical device components involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion 1x16 perc lead kit-50 cm; model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).

Event Description

A report was received that following a non-device related accident, various contacts of the patient's leads were showing high impedances and it fluctuated when the patient moves.X-ray confirmed no lead migration.Database analysis revealed twelve electrodes with high values which vary with each impedance reading.The patient underwent a revision procedure wherein leads were replaced due to malfunction and the splitters were also explanted.The physician assumed that there was lead fracture due to multiple contacts out.The patient was doing well postoperatively.

Event Description

A report was received that following a non-device related accident, various contacts of the patient's leads were showing high impedances and it fluctuated when the patient moves.X-ray confirmed no lead migration.Database analysis revealed twelve electrodes with high values which vary with each impedance reading.The patient underwent a revision procedure wherein leads were replaced due to malfunction and the splitters were also explanted.The physician assumed that there was lead fracture due to multiple contacts out.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2316-50 ((b)(4)) the lead was cut in two pieces.Damage to the lead is a result of a typical explant procedure and it is not considered a failure.X-ray inspections found no cable breakage.Sc-2316-50 ((b)(4)) the complaint was confirmed as one of the lead ((b)(4)) showed fractured cables at the clik site.The lead was cut in two pieces, and several cables were pulled out.The cut damage to the device is a result of a typical explant procedure and it is not considered a failure.X-ray inspections found cable fractures at the bent/kinked section of the lead body apparent a clik anchor site.There are no exposed cables.The fractured cables resulted in the reported complaint.Sc-3400-30 ((b)(4)) one of the tails of the splitter was cut.The cut damage to the device is a result of a typical explant procedure and it is not considered a failure.X-ray inspections found no cable breakage.Sc-3400-30 ((b)(4)) visual/x-ray inspections and impedance test revealed no anomalies.Sc-4316 (ln 16013535) the eyelets were torn, and there was no missing silicon material.

Event Description

A report was received that following a non-device related accident, various contacts of the patient's leads were showing high impedances and it fluctuated when the patient moves.X-ray confirmed no lead migration.Database analysis revealed twelve electrodes with high values which vary with each impedance reading.The patient underwent a revision procedure wherein leads were replaced due to malfunction and the splitters were also explanted.The physician assumed that there was lead fracture due to multiple contacts out.The patient was doing well postoperatively.

• 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: 5547572
• MDR Text Key: 41882368
• Report Number: 3006630150-2016-00787
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2015

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: 01/11/2015
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/06/2016; 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2013
• 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