MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION; DRG INS

Model Number 3664

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/14/2019

Event Type  Injury  

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.

Event Description

It was reported that during the lead replacement procedure (reference mfr report#'s 1627487-2019-03053 and 1627487-2019-03054), the drg ins was unable to communicate.As a result, a ins was explanted and replaced.Therapy was restored post-operatively.

• Type of Device: DRG INS
• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8391838
• MDR Text Key: 137868994
• Report Number: 1627487-2019-03055
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: 05415067020215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2019
• Device Model Number: 3664
• Device Lot Number: 6002072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 109