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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM LEAD, 90 CM; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM LEAD, 90 CM; SCS LEAD Back to Search Results
Model Number 3225
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 07/15/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The investigation results will be provided in the final report.
 
Event or Problem Description
Related manufacturer reference number: 1627487-2019-08751.It was reported the patient experienced ineffective stimulation due to high impedances.X-rays were inconclusive.As a result, the system was explanted and replaced.Issue resolved.
 
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Brand Name
EXCLAIM LEAD, 90 CM
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8856276
Report Number1627487-2019-08747
Device Sequence Number2267740
Product Code LGW
UDI-Device Identifier05415067017758
UDI-Public05415067017758
Combination Product (Y/N)N
Initial Reporter StateAK
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/20/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date07/31/2018
Device Model Number3225
Device Lot Number5614553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/15/2019
Supplement Date Received by Manufacturer09/06/2019
Initial Report FDA Received Date08/02/2019
Supplement Report FDA Received Date09/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MODEL 3716, SCS IPG
Outcome Attributed to Adverse Event Other;
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