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

Model Number SC-2316-50

Device Problems Bent (1059); Fracture (1260); Material Frayed (1262); High impedance (1291); Material Separation (1562)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/20/2014

Event Type  Injury  

Event Description

A report was received that the patient¿s some lead contacts were no longer effective and were showing high impedances.The patient will undergo revision procedure wherein the leads will be replaced.

Event Description

A report was received that the patient¿s some lead contacts were no longer effective and were showing high impedances.The patient will undergo revision procedure wherein the leads will be replaced.

Event Description

A report was received that the patient¿s some lead contacts were no longer effective and were showing high impedances.The patient will undergo revision procedure wherein the leads will be replaced.

Event Description

A report was received that the patient¿s some lead contacts were no longer effective and were showing high impedances.The patient will undergo revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion 1x16 perc lead kit-50 cm.

Manufacturer Narrative

Additional information was received that the patient underwent a lead replacement procedure.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).Additional information was received that the probable cause of high impedance was lead fracture.Malfunction was suspected for the leads.The patient was reportedly doing well postoperatively.

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).Model#: sc-4316, lot #: 16204900, description: next generation anchor kit-sterile.Sc-2316-50 (sn (b)(4)): device evaluation indicated that the proximal portion of the lead was fractured distal of the retention sleeve.The proximal contacts were completely separated from the lead body and it remained inside the associated splitter connector.It showed that each fractured cable was frayed, suggesting that the lead was exposed to excessive tensile force.Review of the device history record revealed no anomalies when the lead was manufactured.The root cause of the damage was unknown.Sc-2316-50 (sn (b)(4)): device evaluation indicated that the associated splitter that contacts # 1-8 of the lead remained inside the splitter connector.The lead proximal array was fractured and completely separated between contact # 8 and 9.Contacts # 9 to 16 were not returned.X-ray inspection showed that each fractured cable was frayed, suggesting that the lead was exposed to excessive tensile force.The root cause of the damage was unknown.Sc-3400-30 (sn (b)(4)): device evaluation indicated that the contact # 1-16 of the fractured associated lead was in the splitter connector.Electrical testing couldn¿t be performed due to the stuck proximal portion of the associated infinion lead inside the splitter connector.Review of the device history record revealed no anomalies when the lead was manufactured.Sc-3400-30 (sn (b)(4)): device evaluation indicated that the splitter connector was bent midline.Contacts # 1-8 of the associated lead is was the splitter connector.Additionally, it revealed that the cable connected to contact # 9 was fractured right at the weld.This anomaly typically occurred when the connector was bent beyond its threshold.Electrical testing couldn¿t be performed due to the stuck proximal portion of the associated lead inside the splitter connector.Review of the device history record revealed no anomalies when the lead was manufactured.Sc-4316 (lot# 16204900): device evaluation indicated that the clik anchors passed visual test performed.Clik anchors revealed no anomalies.

Event Description

A report was received that the patient¿s some lead contacts were no longer effective and were showing high impedances.The patient will undergo revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional information was received that contacts #9 to 16 of the lead that were not returned for analysis were not left inside the patient¿s body.

• 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: 4260199
• MDR Text Key: 4993189
• Report Number: 3006630150-2014-02608
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2014

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: 04/01/2015
• Device Model Number: SC-2316-50
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/22/2014; 01/16/2015; 02/27/2015; 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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
• Patient Age: 62 YR