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

Model Number SC-8336-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 02/25/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator model #: sc-4318 lot #: 19882846 description: clik x anchor the explanted devices were not returned to bsn as they were kept by medical facility.

Event Description

A report was received that the patient was experiencing pain from the posterior to the anterior ribs.Computed tomography (ct) myelogram was taken and it was determined that the paddle was touching a nerve.The patient underwent a revision procedure wherein the ipg and lead were replaced.No device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the reason for the ipg and lead replacement was due to physicians preference.

Event Description

A report was received that the patient was experiencing pain from the posterior to the anterior ribs.Computed tomography (ct) myelogram was taken and it was determined that the paddle was touching a nerve.The patient underwent a revision procedure wherein the ipg and lead were replaced.No device malfunction was suspected.The patient was doing well postoperatively.

• 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: 7346257
• MDR Text Key: 102705948
• Report Number: 3006630150-2018-01059
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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: 04/05/2018

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: 02/04/2019
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2018
• Initial Date FDA Received: 03/16/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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: 58 YR