MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3244

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Paresis (1998); Weakness (2145)

Event Date 04/07/2015

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report#1627487-2015-08260, reference mfr report#1627487-2015-08261.It was reported the patient presented to the emergency room 4 days after undergoing a permanent implant of the scs system with back pain, persistent leg weakness and paresis of the lower limbs.Subsequently, the patient was transported to another hospital at which time an epidural hematoma and hematoma at the ipg site were discovered.Surgical intervention was undertaken on (b)(6) 2015, explanting the scs system and evacuating the hematomas.Follow-up indicated the patient underwent an additional surgery on (b)(6) 2015 for decompression of the low back.Due to the lack of improvement, the physician performed an additional surgery on (b)(6) 2015 whereas another hematoma was observed and evacuated.The patient was placed in the intensive care unit (icu) after surgery and had no bilateral lower movement or extremity sensation.Further follow-up identified the patient was later transferred to a rehabilitation facility with no updated lower extremity improvement.

Event Description

Device 1 of 3 reference mfr report#1627487-08260 reference mfr report#1627487-08261 follow-up identified the patient was hospitalized with pneumonia.Reportedly, there has been no improvement with movement in his lower extremities.The patient was transferred to a nursing home facility for further long-term care.

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

Udi(di) (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.

• Brand Name: LAMITRODE 44 LEAD KIT, 60CM LENGTH
• 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: 4753897
• MDR Text Key: 5828108
• Report Number: 1627487-2015-08259
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

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: 09/28/2015
• Device Model Number: 3244
• Device Lot Number: 4260220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 05/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR