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

Model Number SC-1110

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Charging Problem (2892)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2108-50m, serial #: (b)(4), description: scs lead kit, phase 2 sterile package.

Event Description

A report was received that the patient was experiencing frequent ipg charging.Database analysis showed poor ipg coupling and revealed high impedances on the leads.The patient underwent a revision procedure wherein the entire scs system was replaced.The physician suspected that this was due to scar tissue growth.The patient was reportedly doing well.

Manufacturer Narrative

Sc-1110 (sn: (b)(4)) device evaluation indicated that the complaint regarding the charging anomaly was confirmed.The device lost communication during the memory download procedure.The battery profile logs revealed sudden voltage drops.The device was cut open and the internal inspection revealed erratic internal resistance measurements of the battery when pressure was applied on the case.The battery internal resistance anomaly was due to the intermittent connection to the battery's internal tab and it was the source of the reported charging anomaly.Additionally, the u1- analog ic was damaged.The device exhibited excessive sleep current leakage.The impedance between vh and ground was low.It was reported that bipolar electro cautery was used.Sc-2108-50m (sn: (b)(4)) device evaluation indicated that the complaint had been confirmed.Visual inspection found lead body was bent/kinked/damaged at the suture site and missing proximal end.The fracture location was 21 cm from the distal end.X-ray inspection confirmed all cables were fractured and no cables were exposed.The fractured cables resulted in the reported high impedances.Sc-2108-50m (sn: (b)(4)) device evaluation indicated that the complaint had been confirmed.Visual inspection found lead body was bent/kinked/damaged at the suture site.The fracture location was 16 cm from the distal end.X-ray inspection confirmed all cables were fractured and no cables were exposed.The fractured cables resulted in the reported high impedances.Additional information was received that the patient did not undergo other surgeries prior to the replacement procedure.

Event Description

A report was received that the patient was experiencing frequent ipg charging.Database analysis showed poor ipg coupling and revealed high impedances on the leads.The patient underwent a revision procedure wherein the entire scs system was replaced.The physician suspected that this was due to scar tissue growth.The patient was reportedly doing well.

• 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: 6167656
• MDR Text Key: 62197653
• Report Number: 3006630150-2016-03601
• 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
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2005
• Device Model Number: SC-1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2005
• 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 Age: 55 YR