MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number L331

Device Problems Migration or Expulsion of Device (1395); Pacing Problem (1439)

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

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 the patient implanted with this pacemaker was unable to increase their heart rate to the 140-150 beats per minute (bpm) range with heavy exercise as expected.Review of sensor trend data showed many drop outs to the lower rate limit (lrl) of 50 with peaks around 120-125.It was suspected that the patient was wearing a bluetooth chest strap to track their heart rate during exercise.Boston scientific technical services (ts) was contacted to discuss programming options for optimization.Programming options were discussed and programming changes were made to the sensors and the patient was able to increase their heart rate to the desired rate.It was noted that the patient will no longer wear their bluetooth chest strap while exercising.The patient later reported an accelerated rate that did not match their activity level.An increased rate was reproduced with upper body exercises (specifically left arm movement) and with the patient holding their breath.The patient¿s heart rate increased to the maximum sensor rate of 155 beats per minute (bpm) with left arm movements.It was noted that the patient is very active and participates in competitive rowing and potential anatomy or device movement was suspected to be a factor.Programming changes were made to the sensors and resolved the abrupt rise in heart with left arm movements.The physician had a discussion with the patient regarding not focusing so much on the heart rate, but rather focusing on how they are feeling.This product remains in service.No adverse patient effects were reported.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7618344
• MDR Text Key: 111634850
• Report Number: 2124215-2018-08080
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: (01)00802526559266(17)20180629
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2018
• Device Model Number: L331
• Other Device ID Number: ACCOLADE MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• 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
• Treatment: 5076; 7736; L331
• Patient Age: 68 YR