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

Model Number SC-2218-70

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Telemetry Discrepancy (1629)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/22/2015

Event Type  Injury  

Event Description

A report was received that the patient had loss of stimulation.Database analysis revealed high impedances.A lead replacement was recommended.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2218-70, serial #: (b)(4), description: linear st lead, 70cm.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.

Event Description

A report was received that the patient had loss of stimulation.Database analysis revealed high impedances.A lead and ipg replacement was recommended.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the lead extensions, leads and ipg were replaced.The ipg was replaced per patient's request.During the revision procedure, when the leads were removed from the lead extensions, leads were visibly bent at proximal contacts.One of the leads was cut by the physician to avoid broken contacts from getting stuck in the body prior to explanting the lead.It was also reported that the physician was particularly concerned with the replaced lead extensions because the lead fracture was in the area of extension header/connector.The patient was doing well postoperatively.Additional suspect medical device components involved in the event: model #: sc-3138-25, serial #: (b)(4), description: scs phiii ext 25cm.

Event Description

A report was received that the patient had loss of stimulation.Database analysis revealed high impedances.A lead and ipg replacement was recommended.

Manufacturer Narrative

Sc-2218-70 (sn (b)(4)): device evaluation indicated that all eight cables were fractured at the bent/kinked sections of the lead body, at apparent clik anchor site about 10 centimeters from the proximal tip.No cables were exposed.In addition, e2 was fractured in the proximal array.Sc-2218-70 (sn (b)(4)): device evaluation indicated that the lead body was cut and 5 electrodes of the proximal tip were missing.All eight cables were fractured at the bent/kinked sections of the lead body, at apparent a click anchor site about 8 centimeters from the proximal tip.No cables were exposed.Sc-3138-25 (sn (b)(4)): device evaluation indicated that seven cables were fractured at the distal connector.Sc-3138-25 (sn (b)(4)): device evaluation indicated that the device passed all tests performed.Visual/x-ray inspections and continuity test were performed to ensure the device integrity.No anomalies were found.Sc-1132 (sn (b)(4)): device evaluation indicated that the device passed all tests performed.The complaint regarding that the patient cannot get the remote control to connect to the ipg was not verified.The device was linked to a test remote control and to a wand without any issues.The device profile indicated that the device charging and battery depletion were all normal prior to the explant procedure.The battery depletion rate and sleep current were within the expected range.There was no excessive battery depletion when the device was turned off.The ipg revealed no anomalies.However, the battery level dropped from 3.92 volts to 3.63 volts after the explant procedure.In the lab, the ipg was charged to 4.0 volts in one cycle.It was reported that electrocautery was used during the explant procedure.The sudden drop in voltage could not be duplicated after several charging and discharging cycles.Additional information was received that the contacts broke off after explant, but they were not left in the patient's body.

Event Description

A report was received that the patient had loss of stimulation.Database analysis revealed high impedances.A lead and ipg replacement was recommended.

• 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: 4917207
• MDR Text Key: 6052580
• Report Number: 3006630150-2015-01769
• 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,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2015

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-2218-70
• Other Device ID Number: M365SC2218700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2015; 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2014
• 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: 65 YR