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

Model Number 6662

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

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

Event Date 04/12/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Therapy date is estimate.The implant date is unknown.(b)(6).During processing of this incident, attempts were made to obtain complete device information.

Event Description

It was reported that the patient¿s ipg was replaced on (b)(6) 2022 due to nearing end of life.Reportedly, there was no loss of therapy.

Manufacturer Narrative

The reported observation of ¿eri, ipg approaching end of life¿ was confirmed.The root cause of the reported observation was due to the device having normal battery depletion.The estimated longevity would have been 2.6 years +/-.25-year per ¿ (b)(4), when using the as received programmed settings and assuming 1000-ohm program impedances, for device model 6662.The total stimulation on time was 2.56 years with the device not declaring end of life (eol), suggesting the device had normal battery depletion at the time of the observation.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.Hence, this event is no longer reportable.

• Brand Name: INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS 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: 14251046
• MDR Text Key: 290388639
• Report Number: 1627487-2022-02488
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2021
• Device Model Number: 6662
• Device Catalogue Number: 6662
• Device Lot Number: 7124429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• 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 BURRHOLE CAP SYSTEM; DBS LEAD
• Patient Outcome(s): Other