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

Model Number SC-8120-70

Device Problems Break (1069); Fracture (1260); Material Separation (1562)

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

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-1200, serial #: (b)(4), description : precision montage mri ipg sterile kit.

Event Description

A report was received that the patients lead was fractured and a part of its tail was broken off inside the ipg.The patient underwent an explant procedure.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the location of the missing contacts were unknown.

Event Description

A report was received that the patients lead was fractured and a part of its tail was broken off inside the ipg.The patient underwent an explant procedure.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-8120-70 (b)(4) device evaluation indicated that the complaint of the damaged proximal end was confirmed.Visual inspection revealed that one of the proximal ends was fractured between contact # 4 and 5.Contacts # 1 to 4 were not returned and were not in the ipg port.Additionally, multiple electrodes in the paddle were dislodged but all were still connected to its respected cable.X-ray inspection confirmed that the remaining cables were intact without breakage.Sc-1200 (b)(4) device evaluation indicated that it was confirmed that there was no broken piece of the associated lead tail in the ipg header.Impedance check with known leads and borescope inspection of the header revealed no anomalies.The device passed functional test and revealed no anomalies.

Event Description

A report was received that the patients lead was fractured and a part of its tail was broken off inside the ipg.The patient underwent an explant procedure.The patient 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: 7006104
• MDR Text Key: 91224620
• Report Number: 3006630150-2017-04421
• 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,Followup
• Report Date: 12/13/2017

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: 06/30/2009
• Device Model Number: SC-8120-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 11/09/2017; 11/30/2017
• Supplement Dates FDA Received: 11/24/2017; 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2008
• 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 Outcome(s): Required Intervention