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

Model Number SC-8216-50

Device Problem Material Separation (1562)

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

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device 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 during a revision procedure, reported in mfr report #: 3006630150-2017-03791, the lead did not fit into the epidural space.The physician removed the lead and noticed contacts were detached.It is unknown whether the contacts were removed from the patient.

Manufacturer Narrative

Both adverse event and product problem should be checked.Additional information was received that the detached contacts were removed from the patient.

Event Description

A report was received that during a revision procedure, reported in mfr report #: 3006630150-2017-03791, the lead did not fit into the epidural space.The physician removed the lead and noticed contacts were detached.It is unknown whether the contacts were removed from the patient.

• 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: 6904984
• MDR Text Key: 87791904
• Report Number: 3006630150-2017-03756
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779902
• UDI-Public: 08714729779902
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/01/2017
• Device Model Number: SC-8216-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• 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