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)

Patient Problem Electric Shock (2554)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2218-70, serial #: (b)(4), description: linear st lead, 70cm.Model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.

Event Description

A report was received that the patient was experiencing random electrocution sensation in the hand.It was determined that there were a few contacts out on the lead.It was believed that the shocking sensation when the stimulation was turned on was from a lead fracture.The patient was instructed to leave the stimulator off.The physician, after reviewing the x-ray deemed, it is necessary to replace the leads and the ipg since the magnitude of the electrical shock received by the patient was not known and it is the only way to check whether the battery and leads are working properly.The patient will undergo a replacement of the leads and the ipg.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the ipg and a lead was replaced.The patient was reportedly doing well post operatively.

Event Description

A report was received that the patient was experiencing random electrocution sensation in the hand.It was determined that there were a few contacts out on the lead.It was believed that the shocking sensation when the stimulation was turned on was from a lead fracture.The patient was instructed to leave the stimulator off.The physician, after reviewing the x-ray deemed it necessary to replace the leads and the ipg since the magnitude of the electrical shock received by the patient was not known and it is the only way to check whether the battery and leads are working properly.The patient will undergo a replacement of the leads and the ipg.

Manufacturer Narrative

The source of the complaint was verified to be the associated lead.(b)(4) the ipg passed the functional test and revealed no anomalies.The monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes.Current leakage tests verified no loss of electric current into the surrounding tissue.Residual gas analysis verified that the device insulation was not compromised.(b)(4) four cables were fractured at the bent/kinked section of the lead body.The bent/kinked section of the lead was located at the clik anchor site, 1 cm from the set screw mark.

Event Description

A report was received that the patient was experiencing random electrocution sensation in the hand.It was determined that there were a few contacts out on the lead.It was believed that the shocking sensation when the stimulation was turned on was from a lead fracture.The patient was instructed to leave the stimulator off.The physician, after reviewing the x-ray deemed it necessary to replace the leads and the ipg since the magnitude of the electrical shock received by the patient was not known and it is the only way to check whether the battery and leads are working properly.The patient will undergo a replacement of the leads and the ipg.

• 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: 5154953
• MDR Text Key: 28450486
• Report Number: 3006630150-2015-02627
• 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
• Report Date: 09/16/2015

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: 03/31/2016
• Device Model Number: SC-2218-70
• Other Device ID Number: M365SC2218700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/10/2015; 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2014
• 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: 50 YR