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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3186
Device Problems High impedance (1291); Migration (4003)
Patient Problem Inadequate Pain Relief (2388)
Event Date 08/12/2021
Event Type  Injury  
Manufacturer Narrative
Date of event and therapy date are estimated.During processing of this complaint, attempts were made to obtain patient weight.
 
Event Description
Related manufacturer reference number: 3006705815-2021-04281.It was reported that one of the patient's leads migrated, high impedances were measured at the lead contacts, and the patient lost effective therapy.As a result, surgery occurred in which the lead was explanted and replaced, which resolved the issue.It is not known which of the leads had the issue, so both applicable leads are being reported.
 
Manufacturer Narrative
A patient experienced lead migration was reported to abbott.It was determined that one of the patient's leads migrated, had high impedances, and the patient lost effective therapy.As a result, the patient's the lead was explanted and replaced, which resolved the issue.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
MDR Report Key12393456
MDR Text Key268987646
Report Number3006705815-2021-04282
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067017246
UDI-Public05415067017246
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/13/2020
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000065774
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SCS LEAD; SCS LEAD
Patient Outcome(s) Other;
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