MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM DRG IMPLANTABLE PULSE GENERATOR; DRG IPG

Model Number 3664

Device Problem Disconnection (1171)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 04/21/2020

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.During processing of this complaint, attempts were made to obtain patient weight, but it could not be obtained.

Event Description

Related manufacturer reference numbers: 1627487-2020-04539; 1627487-2020-04540.It was reported that the patient lost stimulation and experienced pain.X-ray imaging confirmed that the leads pulled out of the ipg header and a lead may be rubbing against a nerve.A steroid injection was administered, but the issue was not resolved.As a result, surgery may occur to address the issue.

Event Description

Additional reporting was received that surgery occurred in which the leads were explanted and replaced, which resolved the issue.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: PROCLAIM DRG IMPLANTABLE PULSE GENERATOR
• Type of Device: DRG IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10050270
• MDR Text Key: 190736312
• Report Number: 1627487-2020-04541
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: 7267770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 06/04/2020; 07/16/2020
• Supplement Dates FDA Received: 06/16/2020; 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG LEAD (2); DRG LEAD (2)
• Patient Outcome(s): Other