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

Model Number SC-1200

Device Problems Cut In Material (2454); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical devices component involved in the event: model#: sc-2408-56 serial#: (b)(4) description: avista mri perc lead kit, 56 cm.

Event Description

A report was received that the physician thought the tissue culture technology believed that the patient had reacted to the suturing that the physician used.The patient underwent an explant procedure.No device malfunction was suspected and patient had recent weight loss.The patient was doing well postoperatively.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-4319 lot #: 20289802 description: clik x mri anchor sc-1200 (sn 304804): device evaluation indicated that the returned ipg passed all the required tests and revealed no anomalies.Sc-2408-56 (b)(4), sc-2408-56 (b)(4)device evaluation indicated that the lead body was cleanly cut into pieces.X-ray inspection found no cable fractures.Damage to the device was similar to the typical explant damage and was not considered a failure.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.Sc-4319 (ln 20289802): device evaluation indicated that the clik anchor passed all the required tests and revealed no anomalies.

Event Description

A report was received that the physician thought the tissue culture technology believed that the patient had reacted to the suturing that the physician used.The patient underwent an explant procedure.No device malfunction was suspected and patient had recent weight loss.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: 7027840
• MDR Text Key: 91899638
• Report Number: 3006630150-2017-04464
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2019
• Device Model Number: SC-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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: 29 YR