MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3662

Device Problem Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.

Event Description

Related manufacturer reference number: 3006705815-2021-04311, 3006705815-2021-04312.It was reported the ipg was flipping in the pocket causing discomfort.The ipg was found to be perpendicularly inserted into the skin after flipping multiple times.Diagnostics found one of the leads had high impedances on all contacts.Surgical intervention may take place at a later date to address the issue.Note: it is unknown which lead has the high impedances; therefore both leads are being reported.

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. .

Event Description

Additional information indicates the patient had their ipg explanted and replaced with a smaller ipg in the same pocket and leads explanted and replaced to address their issue.Therapy was restored.

• Brand Name: PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 12394579
• MDR Text Key: 269045901
• Report Number: 3006705815-2021-04310
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: 3662
• Device Catalogue Number: 3662
• Device Lot Number: A000080787
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL # 3186 - LEAD (X2); MODEL # 3186 - LEAD (X2)
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 102