MAUDE Adverse Event Report: ABBOTT SBP DR INDUCTIVE PACEMAKER, JPD; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2152

Device Problems Premature Discharge of Battery (1057); No Pacing (3268)

Patient Problems Syncope (1610); Bradycardia (1751); Syncope/Fainting (4411)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During follow-up, a loss of pacing resulting in bradycardia and patient symptoms were observed.The physician alleges premature battery depletion.Device replacement is anticipated to be performed to resolve the event.The patient was in stable condition.

Event Description

Additional information received indicated the loss of pacing resulted in syncope.The event was resolved by explanting and replacing the device.

Manufacturer Narrative

The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.

Manufacturer Narrative

The reported events of premature battery depletion and no output were confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested, resulting in high current drain, consistent with moisture damage, depleting the battery and resulting in the reported events.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.As a result of this finding, abbott is performing further investigation.

• Brand Name: SBP DR INDUCTIVE PACEMAKER, JPD
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10976786
• MDR Text Key: 220467823
• Report Number: 2017865-2020-22061
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2021

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: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: PM2152
• Device Lot Number: A000021282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/11/2020; 01/29/2021; 03/15/2021
• Supplement Dates FDA Received: 12/18/2020; 02/08/2021; 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q121-CRM-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention