MAUDE Adverse Event Report: MPRI CAPSUREFIX; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number 6940-52

Device Problem Pocket Stimulation (1463)

Patient Problem Muscle Stimulation (1412)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 6936-65 lead, implanted: (b)(6) 1996.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right atrial (ra) lead was causing pocket/chest stimulation.The lead was removed and a new lead was implanted.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7418245
• MDR Text Key: 105103797
• Report Number: 2649622-2018-05089
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980016
• 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
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6940-52
• Device Catalogue Number: 6940-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Date Device Manufactured: 09/18/1998
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR