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

Model Number SC-2218-50

Device Problems Break (1069); Fracture (1260); Kinked (1339); Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

Sc-2218-50 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.Visual inspection revealed the lead body had a pronounced kink approximately 18 cm from the distal end, where the lead appears to have been sutured.All cables were broken /severed at this spot.The fracture site was 1 cm from the clik anchor setscrew mark.This appears to have been caused by fatigue possibly coupled with postural changes/movements.The completely severed cables were the reason for the loss of stimulation.

Event Description

A report was received that during product analysis it was discovered that the lead was fractured.The patient was experiencing loss of stimulation due to lead migration.The patient underwent a lead replacement procedure.The physician believed that the lead was fractured prior to the procedure.

• 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: 6342980
• MDR Text Key: 67800444
• Report Number: 3006630150-2017-00663
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)161008(10)17317394
• 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
• Report Date: 12/30/2016

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: 10/08/2016
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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: 51 YR