MEDTRONIC TELETRACE 9431 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-11 for MEDTRONIC TELETRACE 9431 * manufactured by Medtronic, Inc.

Event Text Entries

[16280938] During october ecg transmission using medtronic teletrace 9431 pt used kitchen sink to wet the electrodes on wrist. Pt than transmitted ecg, but asked operator to check the transmission as it sounded different than ever in the past 8 years. Witness verifies transmission sounded unusual and reported this to pt's mother. Pt's mother contacted electrophysiologist and asked that ecg be reviewed to confirm no problem with transmission. Pt informed operator that wrist electrode bracelet broke during transmission and was told a new adult wrist electrode would be sent immediatley. During transmission of ecg with teletrace in december pt and pt's mother noted transmission sounded differently than was typical and mentioned this. Pt also explained that wrist electrode was broken and was told to use tape temporarily during the transmission. Pt was told ecg transmission was fine, and to pick up new wrist electrodes during visit scheduled in the office end of december. When pt came to clinic no electrodes were available. Pt was told they would be mailed directly from medtronic as the clinic did not have any adult wrist electrodes on hand. Pt was sent new wrist electordes in the mail, but they arrived from the clinic and not medtronic and were pediatric electrodes with a package insert confirming medtronic pediatric wrist electrodes model 9437 dated o8/1986. After pt death, pt's mother contacted medtronic to ask about the pediatric electordes being sent. Rep in medtronic tech support stated that the electrodes would not have been sent from medtornic, and if clinic had asked for replacement electrodes would have been told they no longer manufactured them or the teletrace model 9431 due to a change in the single pin being used and the exposed pin mandate of 1999 affecting telephonic ecg transmitters. Pt's mother was told that the clinic would have been informed of this is 1999 and told to stop using model 9431 but to use model 9531 -blue unit- instead. Concern here is that the mfr no longer sells or distributes the product, so the wrist electrodes must have been pulled from an old unit at the clinic when they learned the wrist electordes for an adult could no longer be ordered from medtronic. Pt was scheduled for replacement of pacemaker. Pt died 3 weeks before with symptoms just prior to death of possible pacemaker or lead malfunction. During ecg transmission with medtronic teletrace unitl on 12/7/05, atrial puls duration was measured at 0. 65 ms. During teletrace transmission on 1/9/06 atrial pulse duration was not measured. Immediately prior to death witness confirms symptoms described were those that would appear if pacemaker stopped functioning. Pt died at her home.
Patient Sequence No: 0, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1036816
MDR Report Key693746
Date Received2006-03-13
Date of Report2006-03-11
Date Added to Maude2006-04-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMEDTRONIC TELETRACE 9431
Generic NameTELETRACE ECG
Product CodeDXH
Date Received2006-03-11
Model Number9431
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key682874
ManufacturerMEDTRONIC, INC
Manufacturer Address* MINNEAPOLIS MN * US

Device Sequence Number: 2

Brand NameMEDTRONIC 4068
Generic NamePACEMAKER LEAD
Product CodeDTB
Date Received2006-03-11
Returned To Mfg2006-01-16
Model Number4068
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Age*
Implant FlagY
Date RemovedV
Device Sequence No2
Device Event Key684122
ManufacturerMEDTRONIC
Manufacturer Address* MINNEAPOLIS MN * US
Baseline Brand NameCAPSUREFIX
Baseline Generic NameIMPLANTABLE PACING LEAD
Baseline Model No4068
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyIMPLANTABLE PACING LEAD
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]24
Baseline PMA FlagY
Premarket ApprovalP9300
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN

Device Sequence Number: 3

Brand NameMEDTRONIC 7960IB THERA DR-I
Generic Name*
Product CodeDXY
Date Received2006-03-11
Returned To Mfg2006-01-16
Model Number7960IB THERA DR-I
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityR
Device Age*
Implant FlagY
Date Removed*
Device Sequence No3
Device Event Key684123
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
001. Death 2006-03-13

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