MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 3006705815-2020-31025.3006705815-2020-31026.It was reported that the patient fell and experienced ineffective therapy.Diagnostic testing revealed high impedance on multiple contacts of one lead.Imaging showed that the lead migrated.Additional information was received that the right-side lead had slightly migrated and the left-side lead had slightly come out of the ipg header.Surgery occurred on (b)(6) 2020 during which the left-side lead was reinserted into the ipg header to address the issue.It is unknown which lead is the right-side lead and which lead is the left-side lead.

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.

• Brand Name: PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10633178
• MDR Text Key: 209952801
• Report Number: 1627487-2020-32047
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2019
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: 5958572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD (X2); PERCUTANEOUS LEAD (X2)
• Patient Outcome(s): Other
• Patient Weight: 82