MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM ELITE 7; SCS IPG

Model Number 3662

Device Problems Device Inoperable (1663); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.(b)(4).

Event Description

It was reported the patient underwent a permanent implant procedure and the programmer was able to communicate with the ipg intra-operatively.A system impedance test was done intra-op which revealed most of the contacts were low.The patient was taken to post-op and it was determined the ipg was unable to communicate with the external devices.Follow up revealed the ipg was explanted and replaced on (b)(6) 2016.The patient reportedly receives effective therapy.

Manufacturer Narrative

The capa was initiated on 2016-02-23 to address the issue in which the ipg experienced loss of power, causing the patient to lose pain relief requiring replacement of the device.Investigation is currently in progress.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.Corrected data: device code & results.

• Brand Name: PROCLAIM ELITE 7
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 5441247
• MDR Text Key: 38331626
• Report Number: 1627487-2016-00702
• Device Sequence Number: 1
• Product Code: GZB
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2017
• Device Model Number: 3662
• Device Lot Number: 5304008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided; 06/02/2017
• Supplement Dates FDA Received: 09/23/2016; 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-060217-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR