MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 4-CH DBS EXTENSION KIT, 50CM; DBS EXTENTION

Model Number 6315

Device Problem Low impedance (2285)

Patient Problems Inadequate Pain Relief (2388); Shaking/Tremors (2515)

Event Date 11/05/2014

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr.Report: 1627487-2014-21752; reference mfr.Report: 1627487-2014-21753.

Event Description

Device 3 of 3.Reference mfr.Report: 1627487-2014-21752, reference mfr.Report: 1627487-2014-21753.

Event Description

Device 3 of 3.Reference mfr.Report: 1627487-2014-21752.Reference mfr.Report: 1627487-2014-21753.

Manufacturer Narrative

This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.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

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

Results: the complaint for ¿ineffective therapy¿ was not confirmed.The report for ineffective therapy cannot be confirmed through product testing alone.Per event details, the complaint is related to patient neurology and therefore cannot be analyzed.As received, extension (6315) passed all functional testing.Inspection of extension (6315) did not identify any physical or functional anomalies that existed prior to the procedure that could have contributed to the reported complaint.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: 1627487-2014-21752.Reference mfr.Report: 1627487-2014-21753.

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.

• Brand Name: 4-CH DBS EXTENSION KIT, 50CM
• Type of Device: DBS EXTENTION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, tx
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; st. jude medical - neuromodulation; 6901 preston road; plano, tx 7502 4
• MDR Report Key: 4288120
• MDR Text Key: 5055014
• Report Number: 1627487-2014-21754
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 6315
• Device Lot Number: 4215413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• 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