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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC.; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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MEDTRONIC, INC.; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) Back to Search Results
Model Number 5487
Device Problems Failure to Capture (1081); Over-Sensing (1438); Connection Problem (2900); Material Integrity Problem (2978)
Patient Problem Cardiac Arrest (1762)
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that, while being paced with an external pulse generator (epg) during a device replacement procedure, the patient went into asystole, with loss of capture and oversensing exhibited.It was noted that the issue arose when the replacement lead and patient cable were being taped down.The patient was paced with an external defibrillator and the connection between the patient cable and lead was adjusted, but the issue persisted.The lead was connected to a pacing analyzer and shown to function normally.The patient cable was replaced, and the patient was able to be paced with the epg and lead without issue.It was noted that the implanting physician attributed the issue to the connector block of the patient cable.The cable was returned for analysis.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product analysis: the complaint could not be confirmed.The cable passed visual inspection and continuity tests with no connection issues identified.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
NA
Type of Device
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7756658
MDR Text Key116232657
Report Number2182208-2018-01431
Device Sequence Number1
Product Code DSA
UDI-Device Identifier20643169307333
UDI-Public20643169307333
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
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 Model Number5487
Device Catalogue Number5487
Device Lot Number648490001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2018
Initial Date FDA Received08/07/2018
Supplement Dates Manufacturer Received08/17/2018
08/08/2018
Supplement Dates FDA Received08/21/2018
10/02/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age87 YR
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