MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SINGLE 8 EXTENSION, 60 CM; SCS EXTENSION

Model Number 3386

Device Problem Temperature Problem (3022)

Patient Problems Pain (1994); Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 01/30/2017

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.

Event Description

Device 3 of 3.Reference mfr report: 1627487-2017-00888, reference mfr report: 1627487-2017-00889.The patient had two extensions with the same lot number.It was reported (b)(6) the patient experienced pain and burning sensations at the ipg pocket site as well as at the extension sites on her waist.Stimulation was no longer effective in the targeted pain areas.In addition the patient also received uncomfortable positional stimulation.Reprogramming was unable to resolve the issue and lead diagnostics were normal.The patient underwent surgical intervention where the ipg, penta lead and two extensions were explanted and replaced with a new ipg and penta lead.Ipg pocket site was relocated from the abdominal area to the buttock area, without any extensions.The patient is now receiving effective stimulation and all issues are reported to be resolved.

Event Description

Device 3 of 3.Reference mfr report: 1627487-2017-00888, reference mfr report: 1627487-2017-00889.

• Brand Name: SINGLE 8 EXTENSION, 60 CM
• 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
• MDR Report Key: 6350548
• MDR Text Key: 68082916
• Report Number: 1627487-2017-00890
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 3386
• Device Lot Number: 5353746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• 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
• Patient Age: 47 YR