MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS PULSE GENERATOR

Model Number 6662

Device Problems Battery Problem (2885); No Apparent Adverse Event (3189)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type  Injury  

Event Description

It was reported that the patient's ipg was nearing end of life but still operable.Surgical intervention was undertaken on (b)(6) 2023 wherein the patient's ipg was explanted, replaced, and therapy was restored.

Manufacturer Narrative

Section b3: date of event is estimated.

Manufacturer Narrative

Correction: manufacturing reference number should not have been reported as a medical device report (mdr).The reported observation of normal ipg battery depletion was confirmed.The root cause of the reported observation was due to the device having normal battery depletion at the time of the observation.The estimated longevity would have been 1.75 years +/-.25-year per ¿ 90205144, when using the as received programmed settings and assuming 500-ohm program impedances, for device model 6662.The total stimulation on time was 1.51 years, suggesting the device had normal battery depletion at the time of the observation.

Event Description

Additional information received indicated that product analysis findings confirmed the ipg exhibited normal battery depletion.

• Brand Name: INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS PULSE GENERATOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17604601
• MDR Text Key: 321757253
• Report Number: 1627487-2023-03977
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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: 03/17/2023
• Device Model Number: 6662
• Device Lot Number: 7940708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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: DBS LEAD BURR HOLE CAP (X2).; DBS LEAD EXTENSION (X2).; DBS LEAD(X2).
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 75 KG