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

Model Number 3660

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 Type  Injury  

Manufacturer Narrative

Event date is unknown.During processing of this complaint, attempts were made to obtain complete event, patient and device information.

Event Description

It was re[ported that the patient was receiving an elective replacement indicator (eri) message and the ipg was inoperable.External devices were unable to connect to the ipg.As a result, surgical intervention may occur to address the issue.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.

Event Description

It was reported that the patient's ipg was explanted and replaced on (b)(6) 2021.The patient has effective therapy post operatively.

Manufacturer Narrative

The reported observation of ¿ipg replacement scheduled¿ was confirmed.The root cause of the reported observation was due to the device having normal battery depletion to the end of life (eol).The device provided therapy per the programming up to the eol declaration date at which time therapy is inhibited.The estimated minimum bol longevity range based on the 3 programs used would have been 1.75 years up to 6.5 years.Program#3 was utilized 82% of the implant period with a longevity estimate of 1.75 years +/-.25-year per ¿ (b)(4), assuming 500-ohm lead impedances for device model 3660.

• Brand Name: PROCLAIM¿ 5 ELITE 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: 12481762
• MDR Text Key: 271706694
• Report Number: 1627487-2021-17044
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6050199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• 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
• Patient Outcome(s): Other
• Patient Sex: Female