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

Model Number PM2152

Device Problem Premature Discharge of Battery (1057)

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

Event Type  Injury  

Event Description

During follow-up, there was premature battery depletion alleged on the device.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

As received, the device was interrogated, and battery had reached end of life (eol) level.A product code download was attempted but was unsuccessful due to low battery level.The device was cut open to enable further testing and an external power supply was connected to power the device.Analysis performed with external power supply found high current drain from the hybrid circuitry.Further isolation of hybrid current leakage was performed, and results were consistent with xena integrated circuit anomaly resulting in the reported anomaly.An assessment of total projected longevity was performed, and premature battery depletion was confirmed.

• 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: 9530810
• MDR Text Key: 173066983
• Report Number: 2017865-2019-18640
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

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: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: PM2152
• Device Lot Number: P000047174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 04/08/2020; 12/19/2020
• Supplement Dates FDA Received: 04/08/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention