MAUDE Adverse Event Report: ABBOTT / ST. JUDE MEDICAL, INC. PM2240; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2240

Device Problems High impedance (1291); Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2023

Event Type  Injury  

Event Description

Separate concerns, patient is a medical professional in ep: device: pm2240 not affected in located batches for recall, but my device is still under preforming on battery, i will reach 10 years battery longevity off of 2.5v at 0.4ms with only 22% ap.Battery dropped in 1 year from 9.5 years to 2 years.Very concerning.Tech services says this is "normal device function but i've never seen in my 12 years in ep a battery reduce this quickly without any changes in pacing/thresholds.Leads: this is my 3rd set of 2088 tendril leads in 8 years.All previous leads failed within 2 years, high impedance, poor sensing, noise.Current leads have now started having the same problems and will now need to have a 3rd extraction in 8 years.These leads have put my life at extreme risk, manufacture is not reporting correctly on their performance reports.Lead noise noted on both leads again.Battery estimation dropped 7.5 years in 12 months.Reference report #mw5115758, #mw5115759, #mw5115760.

• Brand Name: PM2240
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT / ST. JUDE MEDICAL, INC.
• MDR Report Key: 16546828
• MDR Text Key: 311491972
• Report Number: MW5115761
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White