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

Model Number SC-2218-50

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2218-50 serial #: (b)(4) description: linear st lead, 50cm model #: sc-1110-02 serial #: (b)(4) description: precision implantable pulse generator (ipg) model #: sc-4316 lot #: 15683288 description: next generation anchor kit-sterile.

Event Description

A report was received that the patient's leads was showing high impedances.It was noted that the patient had a lead migration and was having non targeted stimulation.No device malfunction was suspected with the explanted products just the leads.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Manufacturer Narrative

The returned ipg (sc-1110-02/(b)(4)) and clik anchor (sc-4316/(b)(4)) were analyzed and no anomalies were found.Sc-2218-50 (sn:(b)(4)) device evaluation indicated that the complaint was confirmed.Two cables were fractured at the kinked site where the clik was positioned.Fracture location is 1 cm from the clik anchor set screw mark.The cable fractures resulted in high impedances and loss of stimulation.No cables were exposed at the site.Sc-2218-50(sn:(b)(4)) device evaluation indicated that the complaint was confirmed.The lead body was cleanly cut into pieces.X-ray inspection found no cable fractures.Damage to the device was similar to the typical explant damage and was not considered a failure.

Event Description

A report was received that the patient's leads was showing high impedances.It was noted that the patient had a lead migration and was having non targeted stimulation.No device malfunction was suspected with the explanted products just the leads.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the patient was experiencing inadequate stimulation.Discharge diagnoses showed mechanical breakdown and dislodgement of the device.

Event Description

A report was received that the patient's leads was showing high impedances.It was noted that the patient had a lead migration and was having non targeted stimulation.No device malfunction was suspected with the explanted products just the leads.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

• Brand Name: PRECISION
• 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: 6850044
• MDR Text Key: 85274065
• Report Number: 3006630150-2017-03407
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2015
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/12/2017; 09/13/2017
• Supplement Dates FDA Received: 09/28/2017; 10/11/2017
• 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 Age: 40 YR