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

Model Number SC-2218-50

Device Problems Break (1069); Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

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¿s lead was out.It was also noted that one lead was fractured or damaged and the physician believed it was due to patient¿s fall while kicking a soccer ball.The fall was not device related.The patient underwent a revision procedure wherein the lead was replaced.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2218-50 (sn:(b)(4)) device evaluation indicated that 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 high impedances observed.There were no exposed cables.

Event Description

A report was received that the patient¿s lead was out.It was also noted that one lead was fractured or damaged and the physician believed it was due to patient¿s fall while kicking a soccer ball.The fall was not device related.The patient underwent a revision procedure wherein the lead was replaced.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: 6311362
• MDR Text Key: 66814371
• Report Number: 3006630150-2017-00480
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)170713(10)18183171
• 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
• Report Date: 01/10/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2017
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• 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: 26 YR