MAUDE Adverse Event Report: MPRI ATTAIN STABILITY QUAD MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 479888

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 04/15/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported by the patient's spouse that the patient died shortly after implant of the cardiac resynchronization therapy defibrillator (crt-d) system.The spouse reported that the patient was "not in good shape" and did not have adequate self-care.The cause of death was received as st elevation myocardial infarction and ventricular arrest.Additional information regarding the circumstances of the patient death have been requested.

Manufacturer Narrative

Product event summary: the proximal portion of the lead was returned, analyzed, and no anomalies were found.Correction: describe event or problem.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patients spouse that the patient died shortly after implant of the cardiac resynchronization therapy pacemaker (crt-p) system.The spouse reported that the patient was "not in good shape" and did not have adequate self-care.The cause of death was received as st elevation myocardial infarction and ventricular arrest.Additional information regarding the circumstances of the patient death have been requested and not received.

• Brand Name: ATTAIN STABILITY QUAD MRI SURESCAN
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10047925
• MDR Text Key: 190653303
• Report Number: 2649622-2020-09183
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169860421
• UDI-Public: 00643169860421
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2022
• Device Model Number: 479888
• Device Catalogue Number: 479888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• 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: 407652 LEAD, 407645 LEAD, W4TR01 CRT-P
• Patient Outcome(s): Death
• Patient Age: 76 YR