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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ADAPTOR CABLE; IMPLANTABLE PACEMAKER PULSE-GENERATOR
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MEDTRONIC, INC. ADAPTOR CABLE; IMPLANTABLE PACEMAKER PULSE-GENERATOR Back to Search Results
Model Number 5103
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2022
Event Type  malfunction  
Event Description
It was reported that the patient cable was returned to service as an associate product and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
Manufacturer Narrative
Concomitant prod continued: 229047 analyzer.Product analysis: at analysis it was determined that the patient cable was damaged.It was noted that one pin was severely bent.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ADAPTOR CABLE
Type of Device
IMPLANTABLE PACEMAKER PULSE-GENERATOR
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key14011583
MDR Text Key288577940
Report Number2182208-2022-01034
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number5103
Device Catalogue Number5103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2022
Initial Date Manufacturer Received 03/16/2022
Initial Date FDA Received04/05/2022
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 Initial
Patient Sequence Number1
Treatment
2090 PROGRAMMER, 2067L RADIOFREQUENCY HEAD
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