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

Model Number SC-8216-70

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2013

Event Type  Injury  

Manufacturer Narrative

Udi= (b)(4).Device evaluation indicated that the distal electrodes #3r, 7r, 8r were partially dislodged from the paddle silicone, but still attached to their respective cables.Electrode #6r was not returned.Device evaluation indicated that the lead was cut approximately 3.5 inches from the distal end and could not be tested.The damage to the lead is consistent with damages done during the explant procedure and are not considered a failure.

Event Description

A report was received that during device analysis, it was revealed that some electrodes were partially dislodged and one electrode was not returned.

Manufacturer Narrative

Additional information was received that everything was removed.Nothing was left inside the patient's body.

Event Description

A report was received that during device analysis, it was revealed that some electrodes were partially dislodged and one electrode was not returned.

• 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: 5572457
• MDR Text Key: 42489251
• Report Number: 3006630150-2016-00875
• 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: 03/16/2016

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: 02/01/2015
• Device Model Number: SC-8216-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2013
• 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: 35 YR