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

Model Number SC-1140

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

Patient Problems Discomfort (2330); Reaction (2414)

Event Date 03/29/2017

Event Type  Injury  

Event Description

A report was received that the patient developed an unpleasant feeling at the ipg pocket site.The patient will undergo a revision or explant procedure.

Manufacturer Narrative

A report was received that the patient underwent an explant procedure wherein all of the patient's devices were removed due to suspected allergic reaction.No device malfunction was suspected.It is unknown if the allergy is device related, however, the physician stated it seems clear that there was no infection.Additional suspect medical device components involved in the event: model #: sc-2366-70 lot #: 3090237 description: linear 3-6 lead, 70cm model #: sc-4316 lot #: 19765827 description: next generation anchor kit-sterile the explanted devices were not returned to bsn.

Event Description

A report was received that the patient developed an unpleasant feeling at the ipg pocket site.The patient will undergo a revision or explant procedure.

Manufacturer Narrative

As the devices involved in the complaint have not been returned, the complaint investigation site (cis) could not perform device analysis.However a review of the complaint report and device history record did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint.

Event Description

A report was received that the patient developed an unpleasant feeling at the ipg pocket site.The patient will undergo a revision or explant procedure.

Manufacturer Narrative

A review of the sterilization documentation for the devices were found to be satisfactory.

Event Description

A report was received that the patient developed an unpleasant feeling at the ipg pocket site.The patient will undergo a revision or explant procedure.

• 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: 6501549
• MDR Text Key: 73092590
• Report Number: 3006630150-2017-01493
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: (01)08714729897835(17)180407(10)19111114
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 03/29/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2018
• Device Model Number: SC-1140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/01/2017
• Supplement Dates FDA Received: 06/02/2017; 06/27/2017; 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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