MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV

Model Number TACHY DEVICE

Device Problems Device Alarm System (1012); Pocket Stimulation (1463); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem Muscle Stimulation (1412)

Event Date 01/01/2007

Event Type  malfunction  

Manufacturer Narrative

A boston scientific customer contact representative discussed and documented the reported issues.The representative attempted to get further details from the patient who was upset and ended the phone call.Efforts to obtain additional product issue details were unsuccessful.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this patient stated this device was implanted eleven years ago with leads implanted on both sides of her neck and one through her abdomen which resulted in muscle spasms every day since implant.She was upset as she had been informed there was nothing that could be done about the spasms.Additionally, eight years ago, she underwent a medical resonance imaging (mri) and the device began emitting tones.She was informed that the device was no longer working and she spent 34 days in the hospital and she believes the device ruined her life.She stated the device was affected by an advisory, but she was not informed of this.Most recently, she was inquiring why a boston scientific representative was sent to check her device as the device hasn't been working since the mri.No adverse patient effects were reported.

• Manufacturer (Section D): GUIDANT PUERTO RICO BV
• Manufacturer (Section G): GUIDANT PUERTO RICO BV
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5372403
• MDR Text Key: 36479577
• Report Number: 2124215-2016-00348
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TACHY DEVICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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