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

Model Number SC-2218-50

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/05/2017

Event Type  Injury  

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-4316 lot#: 15187817 description:next generation anchor kit-sterile.

Event Description

A report was received that the patient was experiencing inadequate stimulation and high impedances were noted.The patient underwent a revision procedure wherein the leads and clik anchor were replaced.No device malfunction was suspected but lead fracture was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2218-50 (sn: (b)(4)) device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that all of the cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the fracture locations.Sc-2218-50 (sn (b)(4)) device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple of the cables were completely broken at the bent/kinked location of the lead.The bent/kinked locations are 1 cm from both sides of the set screw mark of the clik anchor.There are no exposed cables at the fracture location.Sc-4316 (ln: 15187817) device evaluation revealed both anchors have one eyelet torn through.The small piece of silicone was not returned.

Event Description

A report was received that the patient was experiencing inadequate stimulation and high impedances were noted.The patient underwent a revision procedure wherein the leads and clik anchor were replaced.No device malfunction was suspected but lead fracture was suspected.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: 6595177
• MDR Text Key: 76084403
• Report Number: 3006630150-2017-01982
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)140301(10)15099331
• 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: 05/05/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2014
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2012
• 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
• Patient Age: 87 YR