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

Model Number SC-2218-70

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

Section d4 other # field is populated with the di number.Additional suspect medical device components involved in the event: model #: sc-2218-70, serial #: (b)(4), description: linear st lead, 70cm, model #:sc-1110-02, serial #: (b)(4), description: precision implantable pulse generator (ipg), model #: sc-4316, lot #: 17711944, description: next generation anchor kit-sterile.

Event Description

A report was received that the patient stopped feeling stimulation and had high impedance readings.The patient underwent a revision procedure wherein the leads and the anchors were explanted.Also during the procedure, the physician explanted the ipg where fluid infiltration on its ports was noted.The patient was reportedly doing well postoperatively.

Manufacturer Narrative

Device evaluation indicated that the source of the complaint was verified to be the associated leads whose cables were fractured at the clik anchor site, 1 cm from the set screw mark.Sc-1110-02/ sn: (b)(4) device evaluation indicated that the header was contaminated with blood, an impedance measurements were all fine.The ball seals were intact.The device passed the functional test and revealed no anomalies.Sc-2218-70/ sn: (b)(4) device evaluation indicated that five cables were fractured at the bent/kinked sections of the lead body at the clik anchor site.No exposed cables.Sc-2218-70/ sn: (b)(4) device evaluation indicated that four cables were fractured at the bent/kinked sections of the lead body at the clik anchor site.No exposed cables.Sc-4316/ sn: (b)(4) device evaluation indicated that the eyelets were torn, but there was no missing silicone material.

Event Description

A report was received that the patient stopped feeling stimulation and had high impedance readings.The patient underwent a revision procedure wherein the leads and the anchors were explanted.Also during the procedure, the physician explanted the ipg where fluid infiltration on its ports was noted.The patient was reportedly 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: 5248311
• MDR Text Key: 32092790
• Report Number: 3006630150-2015-03046
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• 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: 11/04/2015

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: 01/31/2017
• Device Model Number: SC-2218-70
• Other Device ID Number: M365SC2218700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• 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): Other; Required Intervention