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

Model Number SC-8216-50

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

Patient Problem Nerve Damage (1979)

Event Date 08/16/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-8216-70 serial #: (b)(4) description: artisan surgical lead, 70cm.

Event Description

A report was received that the patient was experiencing numbness in the right arm.X-ray result confirmed that the lead had migrated.The patient underwent a lead revision procedure wherein the lead was moved back into position and was sutured in.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the physician did not suspect numbness was caused by the migrated lead but believed that positioning during surgery may have caused it.

Event Description

A report was received that the patient was experiencing numbness in the right arm.X-ray result confirmed that the lead had migrated.The patient underwent a lead revision procedure wherein the lead was moved back into position and was sutured in.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: 6841054
• MDR Text Key: 84614597
• Report Number: 3006630150-2017-03289
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779902
• UDI-Public: 08714729779902
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2018
• Device Model Number: SC-8216-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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: 41 YR