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

Model Number 459888

Device Problem Device Handling Problem (3265)

Patient Problems Muscle Weakness (1967); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 5076-52 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that during the replacement procedure, the physician threaded the lead into the wrong leg of the vein, and it ended up in the wrong placement.The patient noted that during the replacement procedure, the power went out in the entire city and the generated did not kick in right away.The physician was in the middle of threading the lead into the vein when the power went out.Patient noted that the lead ended up too close to a huge nerve and when the lead was connected to the cardiac resynchronization therapy defibrillator (crt-d), the lead provided therapy.The patient would start jumping around because of the voltages that was felt.Reprograming was done due to the leads being backwards, which was not recognized until afterwards.Patient further reported that during a visit to the clinic, a heart monitor was put on the patient and it showed that during exercising, the patient heart would become slow.The patient reported being so weak that they are unable to get out of bed some days.Reprogramming was done again due to the crt-d getting information backwards.Patient noted that the device would make the heart go lower when exercising because information was sent backwards to the device.Patient noted that the device had to be reprogrammed to work backwards and take in data backwards.Patient noted that the device is working like a ¿charm¿ ever since the reprogramming.The device and leads remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PERFORMA S 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: 11753141
• MDR Text Key: 248200825
• Report Number: 2649622-2021-08759
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601871
• UDI-Public: 00643169601871
• 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
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/12/2020
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Date Device Manufactured: 01/24/2018
• 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: 6935M62 LEAD, DTBA1QQ CRT-D
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR