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

Model Number SC-3138-35

Device Problem Cut In Material (2454)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: model #: sc-3138-35, serial #: (b)(4), description: scs phiii ext 35cm.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patient was experiencing inadequate stimulation.The patient underwent a revision procedure wherein the ipg was replaced.No device malfunction was suspected with the ipg.During the procedure while the extensions were removed from the lead, it was noted that the lead looked weird as it had a very wide space.The very end of the lead contact was cut off, and appeared to be damaged.The physician could not verify if the issue was from the device.However, when the physician plugged the lead into the header, everything lined up well.The patient was doing well postoperatively.No further course of action.

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: model #: sc-3138-35, serial #: (b)(4), description: scs phiii ext 35cm.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

A report was received that the patient was experiencing inadequate stimulation.The patient underwent a revision procedure wherein the ipg was replaced.No device malfunction was suspected with the ipg.During the procedure while the extensions were removed from the lead, it was noted that the lead looked weird as it had a very wide space.The very end of the lead contact was cut off, and appeared to be damaged.The physician could not verify if the issue was from the device.However, when the physician plugged the lead into the header, everything lined up well.The patient was doing well postoperatively.No further course of action.

• 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: 5321729
• MDR Text Key: 34196782
• Report Number: 3006630150-2015-03333
• 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,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2009
• Device Model Number: SC-3138-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2008
• 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 Age: 49 YR