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

Model Number SC-1200

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

Patient Problem Skin Erosion (2075)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-2408-56 serial#: (b)(4) description: avista mri perc lead kit, 56cm model#: sc-4319 lot#: 21176532 description: clik x mri anchor.

Event Description

A report was received that the patients ipg was protruding.It was confirmed that there was actual skin breakage.The patient underwent an explant procedure.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-1200 (b)(4) device evaluation indicated that the ipg passed all tests performed.Sc-2408-56 (b)(4) device evaluation indicated that the leads passed all tests performed.Sc-4319 (ln:21176532) device evaluation indicated that the clik anchor passed all tests performed.

Event Description

A report was received that the patients ipg was protruding.It was confirmed that there was actual skin breakage.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: 7580813
• MDR Text Key: 110444129
• Report Number: 3006630150-2018-01968
• 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: 07/24/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/02/2019
• Device Model Number: SC-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• 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: 56 YR