MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 110 CM; SCS LEAD

Model Number 3161

Device Problem Detachment Of Device Component (1104)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

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 2 of 3: reference mfr.Report#:1627487-2017-03373, reference mfr.Report#:1627487-2017-03384.It was reported the patient suffered an accident where the ipg was caught on the edge while walking around a corner.The patient stated afterward the event, the ipg was unable to communicate with the external devices (reference mfr.Report#: 1627487-2017-03327).Fluoroscopy confirmed the leads have pulled from the ipg header.Surgical intervention may be taken to address the issue.

Event Description

Device 2 of 3, reference mfr.Report#:1627487-2017-03373.Reference mfr.Report#:1627487-2017-03384.Follow-up information revealed the patient underwent surgical intervention wherein the ipg was explanted and replaced.Effective stimulation was restored following the procedure.

Manufacturer Narrative

(b)(6).

Event Description

Device 2 of 3, reference mfr.Report#:1627487-2017-03373.Reference mfr.Report#:1627487-2017-03384.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 110 CM
• Type of Device: SCS LEAD
• 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: 6665456
• MDR Text Key: 78343908
• Report Number: 1627487-2017-03374
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 3161
• Device Catalogue Number: 3161
• Device Lot Number: 3286413
• Other Device ID Number: 0541473440184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2011
• 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
• Patient Age: 57 YR
• Patient Weight: 85