MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA®; 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 08/20/2015

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-2218-70 serial #: (b)(4) description: linear st lead, 70cm.

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted on leads.The patient will undergo lead replacement procedure.

Manufacturer Narrative

Additional information was received that database analysis showed that the impedance measurements revealed high values on several contacts on the leads and were not functioning.

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted on leads.The patient will undergo lead replacement procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein two leads were replaced due to suspected fracture.The patient was reportedly doing well post operatively.

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted on leads.The patient will undergo lead replacement procedure.

Manufacturer Narrative

Sc-2218-50 (sn (b)(4)) 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 locations are 1 cm from both sides of the set screw mark of the clik anchor.There are no exposed cables at the fracture locations.Sc-2218-50 (sn (b)(4)) the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that 2 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.

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted on leads.The patient will undergo lead replacement procedure.

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted on leads.The patient will undergo lead replacement 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: 5165660
• MDR Text Key: 28837960
• Report Number: 3006630150-2015-02675
• Device Sequence Number: 1
• Product Code: LGW
• 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: Followup,Followup,Followup,Followup
• Report Date: 08/20/2015

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: 07/31/2016
• Device Model Number: SC-2218-50
• Other Device ID Number: M365SC2218500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/13/2015; 11/30/2015; 01/08/2016; 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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: 52 YR