MAUDE Adverse Event Report: MPRI SCREW-IN LEAD; ELECTRODE, PACEMAKER, PERMANENT

Model Number 5071-35

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 02/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that approximately three weeks post implant high impedance was noted on the left ventricular (lv) lead.It was further noted that impedance measurements are now stable within normal limits during office interrogation with patient body movements as well as pocket manipulation.It was noted the patient feels very well.The lead remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the left ventricular pacing lead was beyond the expected upper range.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was further reported that the cardiac resynchronization therapy defibrillator (crt-d) set screw was not seated properly and the lead pin had backed up.The lead pin was re-seated in the header and the set screw tightened appropriately.The crt-d remains in use.

• Brand Name: SCREW-IN LEAD
• Type of Device: ELECTRODE, PACEMAKER, PERMANENT
• 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: 9810686
• MDR Text Key: 182700161
• Report Number: 2649622-2020-04895
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169638594
• UDI-Public: 00643169638594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120017
• 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,Followup,Followup,Followup
• Report Date: 04/21/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/21/2021
• Device Model Number: 5071-35
• Device Catalogue Number: 5071-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 04/08/2020; 04/07/2020
• Supplement Dates FDA Received: 03/19/2020; 04/20/2020; 04/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• 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: 6947M55 LEAD, DTMA1D4 CRTD, 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR