MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION LAMITRODE TRIPOLE 16; SCS LEAD

Model Number 3219

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Seizures (2063); Inadequate Pain Relief (2388)

Event Date 03/03/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2014-21202.It was reported the patient experienced a seizure and fell a week ago.Subsequently, the patient experienced pain at the ipg site and loss of stimulation.F/u identified the patient experiences shocking (with stimulation) only when he touches the ipg site.The patient declined programming.X-rays and diagnostics did not reveal anomalies.Subsequently, the patient's ipg was explanted and replaced.The lead tested normal intra-operatively.The patient is receiving effective stimulation post-operatively and there are no further shocking sensations.

Manufacturer Narrative

Sjm has limited info 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: LAMITRODE TRIPOLE 16
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 3733441
• MDR Text Key: 4307970
• Report Number: 1627487-2014-21203
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/11/2014

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: 12/01/2014
• Device Model Number: 3219
• Device Lot Number: 3878147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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: 39 YR