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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

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MEDTRONIC SINGAPORE OPERATIONS ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number ADVDD01
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Edema (1820); Fatigue (1849); Heart Failure (2206)
Event Date 05/05/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
In response to the advisory describing the potential for device circuit error to occur while the device is processing an atrial-sensed event, the implantable pulse generator (ipg) was initially prophylactically reprogrammed.The patient did not tolerate the non-susceptible mode, experiencing an increase in heart failure symptoms, including swelling and fatigue, so the device was later explanted and replaced.No device malfunction was observed while the device was in use, however, given the potential for loss of device functionality the ipg was explanted and replaced to preclude harm to the patient.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ADAPTA
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG  486056
Manufacturer (Section G)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG   486056
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9261090
MDR Text Key164454423
Report Number3008973940-2019-02947
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
P980035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/19/2019
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? No
Device Operator Lay User/Patient
Device Expiration Date12/14/2018
Device Model NumberADVDD01
Device Catalogue NumberADVDD01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/21/2019
Initial Date FDA Received10/31/2019
Supplement Dates Manufacturer Received12/17/2019
Supplement Dates FDA Received12/19/2019
Date Device Manufactured06/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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