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

Model Number SC-8216-70

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 05/08/2018

Event Type  Injury  

Event Description

A report was received that the patient¿s lead had pulled out of the epidural space.It was noted that the contacts had fallen off the lead.The physician confirmed that he did the best to suction out the contacts but it was impossible to determine if everything was removed.The patient underwent an explant procedure and was doing well postoperatively.

Manufacturer Narrative

Sc-8216-70 (b)(4) device evaluation indicated that the lead pulled out of the epidural space and the electrodes had fallen off the paddle lead.Visual inspection revealed missing electrodes e5, e15 and partially dislodge electrodes as well.The cause of the damage couldn't be determined.

Event Description

A report was received that the patient¿s lead had pulled out of the epidural space.It was noted that the contacts had fallen off the lead.The physician confirmed that he did the best to suction out the contacts but it was impossible to determine if everything was removed.The patient underwent an explant procedure and was doing well postoperatively.

• Brand Name: PRECISION MONTAGE MRI
• 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: 7558265
• MDR Text Key: 109707659
• Report Number: 3006630150-2018-01708
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779919
• UDI-Public: 08714729779919
• 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: 07/10/2018

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: Lay User/Patient
• Device Expiration Date: 03/20/2019
• Device Model Number: SC-8216-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• 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: 50 YR