MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 429888

Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Stimulation (1412); Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient called to report ¿getting involuntary muscle spasms¿ in abdomen and it only happens when patient lays on back.When the patient stands up and it goes.Follow up confirmed the patient experienced diaphragmatic stimulation on the left ventricular (lv) lead.The lead was reprogrammed and remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PERFORMA
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• 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: 7700135
• MDR Text Key: 114363688
• Report Number: 2649622-2018-11728
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601833
• UDI-Public: 00643169601833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2019
• Device Model Number: 429888
• Device Catalogue Number: 429888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 01/10/2018
• 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: DTMA1QQ ICD, 5076-45 LEAD, 6935M62 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR