MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR; DBS IPG

Model Number 6660

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

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

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer report number: 1627487-2022-07059.It was reported that the patient's ipgs were inoperable.It is unknown when the patient lost therapy.Surgical intervention was undertaken wherein the ipgs were explanted and replaced.Effective therapy was established post operatively.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information was received that the ipg met or exceeded 75% expected longevity.There is no device malfunction.

• Brand Name: INFINITY¿ 5 IMPLANTABLE PULSE GENERATOR
• Type of Device: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16043540
• MDR Text Key: 306093329
• Report Number: 1627487-2022-07050
• Device Sequence Number: 1
• Product Code: MHY
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2018
• Device Model Number: 6660
• Device Catalogue Number: 6660
• Device Lot Number: 5731519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• 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: BURR HOLE CAP X 2; DBS EXTENSION X 2; DBS LEAD; DBS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 77 KG