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

Model Number SC-1200

Device Problems Failure to Charge (1085); Overheating of Device (1437); Telemetry Discrepancy (1629); Battery Problem: Low Impedance (2973); Wireless Communication Problem (3283)

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

Event Date 03/05/2018

Event Type  malfunction  

Event Description

A report was received that the patient was unable to get the ipg charged up.It was noted that the ipg was close to the surface of the skin.Device malfunction was suspected.The patient will undergo a revision procedure wherein the ipg will be replaced.

Manufacturer Narrative

Sc-1200 (b)(4) device evaluation indicated that the complaint was confirmed.The u1 application ic was damaged.The device would not be charged nor linked to a test remote control even after two charging attempts.The device was cut open, and the battery measured 3.9 volts.The device exhibited excessive sleep current leakage.A hot spot was observed on the component (28.0°c).The impedance between vh and ground was low.The reported complaint states patient underwent to mri and the ipg would not communicate immediately after the mri.

Event Description

A report was received that the patient was unable to get the ipg charged up.It was noted that the ipg was close to the surface of the skin.Device malfunction was suspected.The patient will undergo a revision procedure wherein the ipg will be replaced.

Manufacturer Narrative

Additional information was received that the patients rc would not communicate with ipg after a magnetic resonance imaging (mri).The patient underwent an ipg replacement procedure and was doing well postoperatively.

Event Description

A report was received that the patient was unable to get the ipg charged up.It was noted that the ipg was close to the surface of the skin.Device malfunction was suspected.The patient will undergo a revision procedure wherein the ipg will be replaced.

• 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: 7511552
• MDR Text Key: 108238199
• Report Number: 3006630150-2018-01671
• 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,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2017
• Device Model Number: SC-1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• 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 Age: 60 YR