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

Model Number 419688

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Muscle Stimulation (1412); Muscle Spasm(s) (1966)

Event Date 09/02/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 2088tc, lead implanted (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that their lead, which had no "barb" so that it could be inserted into a small vein, was "shocking" them one day post-implant.The patient does have a left ventricular (lv) lead with no "barb" or fixation mechanism.The patient further described the sensation as muscle spasms.The lead was reportedly "disconnected" in office per the patient.Follow up yielded no further information.The lead remains implanted.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY
• 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: 7094575
• MDR Text Key: 94075045
• Report Number: 2649622-2017-15438
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601772
• UDI-Public: 00643169601772
• 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: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/22/2018
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Date Device Manufactured: 01/23/2017
• 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: C4TR01 CRT-P, 5076 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR