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

Model Number SC-1140

Device Problems High impedance (1291); Material Separation (1562)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 11/19/2016

Event Type  Injury  

Event Description

A report was received that the patient was experiencing shocking sensation when the stimulation was turned on.It was also noted that the patient had three contacts out, the leads were bulging out of his back and was coming out of the ipg confirmed through fluoroscopy exam.The patient will undergo a revision procedure wherein the ipg will be replaced.

Manufacturer Narrative

Additional information was received that the shocking sensation was located in the mid-back of the patient.

Event Description

A report was received that the patient was experiencing shocking sensation when the stimulation was turned on.It was also noted that the patient had three contacts out, the leads were bulging out of his back and was coming out of the ipg confirmed through fluoroscopy exam.The patient will undergo a revision procedure wherein the ipg will be replaced.

Manufacturer Narrative

Correction to fu #1 mdr: additional information was received that the shocking sensation was located in the mid-back of the patient.Additional suspect medical device components involved in the event: model#: sc-8120-50, serial #: (b)(4), description: artisan surgical lead, 50cm.Model#: sc-2208-50, serial #: (b)(4), description: st linear lead 50cm.

Event Description

A report was received that the patient was experiencing shocking sensation when the stimulation was turned on and the patient felt as if the leads were bulging out of his back.High impedances were observed on three of the contacts.The physician confirmed, through fluoroscopy, that the lead was coming out of the ipg.The patient will undergo a revision procedure wherein the ipg will be replaced.

Manufacturer Narrative

Additional information was received that no further course of action will be taken at this time.

Event Description

A report was received that the patient was experiencing shocking sensation when the stimulation was turned on and the patient felt as if the leads were bulging out of his back.High impedances were observed on three of the contacts.The physician confirmed, through fluoroscopy, that the lead was coming out of the ipg.The patient will undergo a revision procedure wherein the ipg will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg replacement procedure and was doing well postoperatively.No device malfunction was suspected.The explanted device was not returned to bsn as it was discarded by the medical facility.

Event Description

A report was received that the patient was experiencing shocking sensation when the stimulation was turned on and the patient felt as if the leads were bulging out of his back.High impedances were observed on three of the contacts.The physician confirmed, through fluoroscopy, that the lead was coming out of the ipg.The patient will undergo a revision procedure wherein the ipg will be replaced.

• Brand Name: PRECISION NOVI
• 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: 6590966
• MDR Text Key: 75959771
• Report Number: 3006630150-2017-01917
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: (01)08714729897835(17)171208(10)18692367
• 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,Followup,Followup
• Report Date: 07/31/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2017
• Device Model Number: SC-1140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/25/2017
• Supplement Dates Manufacturer Received: Not provided; 05/25/2017; 06/07/2018; 07/06/2018
• Supplement Dates FDA Received: 06/13/2017; 07/24/2017; 06/28/2018; 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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