MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 20CM; SCS EXTENSION

Model Number 3382

Device Problems Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

It is unknown what devices were explanted.Hence, entire scs system is being reported.Date of explant is unknown.Date of event is unknown.Concomitant medical products scs ipg, scs lead and scs extension, therapy date unknown.The results / method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2019-09001, related manufacturer reference number: 1627487-2019-09002, related manufacturer reference number: 1627487-2019-09004.It was reported that the patient¿s device was removed years ago.It is unknown when and why the device was removed.Patient declined to provide additional information.

Manufacturer Narrative

Date of explant: exact date of explant unknown.Further information was requested but unable to obtain.A system explant was reported to abbott.The patient reported their system did not relive them from pain and the battery site was painful at all times.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2019-09001; related manufacturer reference number: 1627487-2019-09002; related manufacturer reference number: 1627487-2019-09004; new information received indicates that the patient experienced ineffective therapy.As such, the scs system was explanted in (b)(6) 2019 (exact date unknown).

• Brand Name: EXTENSION, 20CM
• Type of Device: SCS EXTENSION
• 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: 8879417
• MDR Text Key: 153843857
• Report Number: 1627487-2019-09003
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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: 05/28/2013
• Device Model Number: 3382
• Device Lot Number: 3383516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other