MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION CINCH ANCHOR; SCS CINCH ANCHOR

Model Number 1194

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/01/2013

Event Type  Injury  

Event Description

Device #3 of 4.Reference mfr report: 1627487-2014-26504, 1627487-2014-26505, 1627487-2014-26506.The pt has a scs system which includes two anchors from the same lot.The pt reports that she has not been receiving stimulation and has been unable to communicate with or recharge her ipg for the past year approximate date (b)(6) 2013 (exact date unk).The pt reports she had to recharge her scs system frequently one year ago and she was unable to keep the system turned on for an entire day.In addition, the pt reports her back stings and wants the scs system removed.Surgical intervention may be pending to address this issue.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: CINCH ANCHOR
• Type of Device: SCS CINCH ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 3919147
• MDR Text Key: 4581788
• Report Number: 1627487-2014-26507
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2009
• Device Model Number: 1194
• Device Lot Number: 171482
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2008
• 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: 64 YR