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

Model Number SC-2218-50

Device Problems Bent (1059); Fracture (1260); Kinked (1339)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 additional suspect medical device component involved in the event: model#: sc-2218-50 serial #: (b)(4) description: linear st lead, 50cm.

Event Description

A report was received that the patient had loss of stimulation in the right side.It was noted that the wires in the right sided lead had fractured.The patient had pain problem caused by the stimulator implant.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Event Description

A report was received that the patient had loss of stimulation in the right side.It was noted that the wires in the right sided lead had fractured.The patient had pain problem caused by the stimulator implant.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Sc-2218-50 (sn (b)(4)): device evaluation indicated that the complaint had been confirmed.X-ray inspection of the leads revealed that multiple cables were completely broken at the bent/kinked location of the leads.The bent/kinked location was 1 cm from the set screw mark of the clik anchor.There were no exposed cables at the fracture location.Electrical tests could not be performed due to broken cables.

Event Description

A report was received that the patient had loss of stimulation in the right side.It was noted that the wires in the right sided lead had fractured.The patient had pain problem caused by the stimulator implant.The patient will undergo a revision procedure wherein the leads will be replaced.

• 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: 6439801
• MDR Text Key: 71038700
• Report Number: 3006630150-2017-01102
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)140101(10)14933252
• 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: 11/21/2016

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: 01/01/2014
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2017; 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2012
• 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