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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; PERCUTANEOUS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD Back to Search Results
Model Number 3186
Device Problems Low impedance (2285); Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
 
Event Description
Related mfr reports: 3006705815-2021-02535 and 3006705815-2021-02536.It was reported the patient's scs system was exhibiting low impedance on multiple lead contacts.Reportedly, the patient controller displayed error message "mri is not advised, there may be a problem with the implanted leads" when attempting to set the scs system into mri mode.Surgical intervention may be taken to address the issue.
 
Manufacturer Narrative
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.
 
Event Description
Related mfr reports: 3006705815-2021-02535 and 3006705815-2021-02536.
 
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Brand Name
OCTRODE LEAD KIT, 60CM LENGTH
Type of Device
PERCUTANEOUS 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 Key11860396
MDR Text Key251841129
Report Number3006705815-2021-02534
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,health
Type of Report Initial,Followup
Report Date 06/28/2021
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
Device Operator Health Professional
Device Expiration Date06/26/2020
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000060671
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/04/2021
Initial Date FDA Received05/20/2021
Supplement Dates Manufacturer Received06/22/2021
Supplement Dates FDA Received06/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MODEL 3186, SCS LEAD; MODEL 3660, SCS IPG; MODEL 3186, SCS LEAD; MODEL 3660, SCS IPG
Patient Outcome(s) Other;
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