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

Model Number SC-8216-50

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that the patient experienced loss of stimulation.High impedances were showing on the lead.Database analysis also revealed high impedances on lead contacts.The patient will undergo a revision procedure wherein the lead will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the lead was replaced.Device malfunction was suspected due to high impedances showing when tested.It was noted that the lead was further damage during the explant procedure.The patient was doing well postoperatively.

Event Description

A report was received that the patient experienced loss of stimulation.High impedances were showing on the lead.Database analysis also revealed high impedances on lead contacts.The patient will undergo a revision procedure wherein the lead will be replaced.

Manufacturer Narrative

Device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that 8 cables were fractured at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.The fractured cables resulted in the reported high impedance complaint.No cables are exposed at the fracture site.Additionally, visual inspection also found a setscrew mark located between the edge of retention sleeve and the contact#8.The setscrew mark indicates that proximal end of the paddle lead was not fully inserted into the ipg header.

Event Description

A report was received that the patient experienced loss of stimulation.High impedances were showing on the lead.Database analysis also revealed high impedances on lead contacts.The patient will undergo a revision procedure wherein the lead will be replaced.

• 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: 5563552
• MDR Text Key: 42193513
• Report Number: 3006630150-2016-00828
• 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: Initial,Followup,Followup
• Report Date: 02/29/2016

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: 07/01/2014
• Device Model Number: SC-8216-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/06/2016; 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2012
• 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: 70 YR