IMPLANTABLE DEFIBRILLATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for IMPLANTABLE DEFIBRILLATOR manufactured by St Jude Medical / Abbott Laboratories.

Event Text Entries

[140280631] I have a st jude icd with home monitor. The device was placed (b)(6) 2017. I was just informed by st jude on 03/22/2019 after repeated questions that my home monitor has not worked since (b)(6) 2018, more than 14 months. St jude attempted to blame (b)(6) for failing to inform me after st jude informed (b)(6). I spoke with (b)(6) on (b)(6) 2019 and they said they never received a notice from st jude. I transferred care to (b)(6) in (b)(6) 2019. I informed st jude of the change and received my new card with the correct (b)(6) dr. On 03/22/2019, st jude informed me that i also needed to contact the st jude monitoring dept in order to change providers. There is nothing to explain that nor written instructions. The st jude rep promised to overnight a new home monitor unit. On (b)(6) 2019, 48 hrs later no unit. St jude is not open on weekends. My dr's office had me go to the er for chest pain and to check the icd. (b)(6) attempted to check the unit on their machine. Their unit was unable to transmit as well. I had to stay overnight and the following day, st jude rep was able to interrogate the unit which is different than the transmit problem. The home unit failed after 8 months. No one informed me of this. If i had not questioned st jude on (b)(6) 2018, i would still now know. I do not have any answers. (b)(6) has admitted that "i felt through the cracks and they did not follow nor check for transmit problems. " i have been left without home monitoring for more than 14 months and no solution is in site. (b)(6) has admitted that they did not follow protocol in enrollment that would have showed the home monitor was not working on (b)(6) 2019. The unit is still showing a green light.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085201
MDR Report Key8456337
Date Received2019-03-26
Date of Report2019-03-24
Date of Event2018-01-04
Date Added to Maude2019-03-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameIMPLANTABLE DEFIBRILLATOR
Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Product CodeLWS
Date Received2019-03-26
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerST JUDE MEDICAL / ABBOTT LABORATORIES

Device Sequence Number: 2

Brand NameMERLIN@HOME TM TRANSMITTER
Generic NamePACEMAKER / ICD / CRT NON-IMPLANTABLE COMPONENTS
Product CodeOSR
Date Received2019-03-26
Model NumberEX1150
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerST JUDE MEDICAL / ABBOTT LABORATORIES


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening 2019-03-26

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