MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.

Event Description

It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The device had the appropriate level of battery voltage to provide therapy.The device was explanted and replaced on (b)(6) 2021.The patient has effective therapy.

Manufacturer Narrative

Analysis of the records show that the battery voltage level of the device is within specifications.Actions have been taken to prevent reoccurrence.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12280831
• MDR Text Key: 265166104
• Report Number: 1627487-2021-16127
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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: 06/27/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6031798
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/09/12/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 52