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

Model Number SC-8120-70

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2017

Event Type  Injury  

Event Description

A report was received that during the revision procedure, the physician cut through part of the patient's one of the leads.The physician chose to proceed with the case and plugged both leads.Impedances were noted on the lead had been damaged.The physician chose to leave the paddle in place to see how coverage was postoperatively.The bsn representative was able to obtain good stimulation to the patient using the lead that was intact.The patient was doing well and does not have complications related to the procedure at this time.

• Brand Name: PRECISION
• 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: 6685392
• MDR Text Key: 79024455
• Report Number: 3006630150-2017-02413
• 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: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2010
• Device Model Number: SC-8120-70
• Other Device ID Number: M365SC8120700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2009
• 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: 64 YR