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

Model Number 3660

Device Problem Pocket Stimulation (1463)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 02/19/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced a shocking sensation at their scs ipg site following a car accident where they were rear ended in their vehicle.The patient stated that they did not experience any shocking sensations prior to the event.In turn, the patient underwent surgical intervention to explant and replace the device to address the shocking sensation at the ipg site.The device was returned for analysis and investigation is ongoing.

Manufacturer Narrative

The reported shocking issue was not confirmed.Analysis of the returned ipg found it was responsive and communicated with all lab utilities.The ipg was tested to manufacturing specifications using the ate and passed all tests.When attached to a 1k ohm load block, programmed and monitored with an oscilloscope, it did not display any anomalous outputs when stimulation was on as well as off.The magnet feature functioned as intended.No physical or functional anomaly that would contribute to the reported issues was observed.The returned ipg functioned as intended.Date of event is estimated.

• 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: 12173266
• MDR Text Key: 261694111
• Report Number: 1627487-2021-15635
• 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
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 5876944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79