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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS PADDLE LEAD

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ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS PADDLE LEAD Back to Search Results
Model Number 3286
Device Problem Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative

Patient identifier is unknown. Date of event is estimated. Device information is unknown. Date of implant is unknown. The unique device identifier (udi #) is unknown because the lot and part number were not provided the results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer reference numbers: 3006705815-2020-30724, 1627487-2020-23946. It was reported that the patient experienced ineffective stimulation following a fall where the patient landed on their ipg pocket site. Imaging showed that the patient's leads had pulled-out of the ipg header. The patient underwent surgical intervention on (b)(6) 2020 to reconnect the leads. Intraoperative testing showed high impedances on multiple contacts. In turn, the physician decided to explant and replaced the entire scs system. Post-operatively, stimulation therapy was restored.

 
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Brand NameLAMITRODE S-8 LEAD KIT, 60CM LENGTH
Type of DeviceSCS PADDLE 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
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10400054
MDR Text Key202689165
Report Number1627487-2020-23947
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeRQ
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3286
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/06/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/16/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/12/2020 Patient Sequence Number: 1
Treatment
SCS IPG; SCS PADDLE LEAD
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