FDA.reportPublic FDA data

MAUDE MDR 9898532

MDR report key
9898532
Report number
3008642652-2020-02710
Event key
0
Event type
3
Date of event
2020-02-15
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ELIZA SCHALLY
Address
121 GAMMA DRIVE PITTSBURGH, PA US
Phone
968-968-9683
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIFEVEST WCD 4000 SYSTEMWEARABLE CARDIOVERTER DEFIBRILLATORZOLL MANUFACTURING CORPORATIONMVKWCD 400010A0988R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3001. D; 2. O

Event Narratives#

N

Patient 1

DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION CONNECTORS J703 AND J704 WERE PULLED FROM THE DISTRIBUTION NODE PCA AND BROKEN. ADDITIONALLY, THE CABLES CONNECTING ECG C AND D AND THE ECG C AND D ELECTRODE DOMES WERE MISSING. THERE IS NO INDICATION THAT THE DAMAGED ELECTRODE BELT CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. REVIEW OF THE PATIENT'S DOWNLOAD DATA FROM THE EVENT DOES NOT INDICATE A PRODUCT MALFUNCTION. THE ROOT CAUSE FOR THE DAMAGED CONNECTORS COULD NOT BE POSITIVELY IDENTIFIED. MONITOR SN (B)(4) HAS BEEN RETURNED TO ZOLL MANUFACTURING CORPORATION BUT HAS NOT BEEN EVALUATED YET. DEVICE EVALUATION INCLUDES REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAYS SURROUNDING THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT TREATMENT. MANUFACTURE DATE: MONITOR - (B)(4) - 02/04/2013, BELT - (B)(4) - 09/07/2015.

D

Patient 1

A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED PASSED AWAY ON (B)(6) 2020. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALS THAT THE PATIENT EXPERIENCED A DEFIBRILLATION EVENT CONSISTING OF FOUR SHOCKS ON (B)(6) 2020 AND (B)(6) 2020. AT 12:34:53 ON (B)(6) 2020, THE LIFEVEST DETECTED VENTRICULAR TACHYCARDIA (VT) AND DELIVERED AN APPROPRIATE TREATMENT. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 40 BPM. LATER, AT 02:02:14 ON (B)(6) 2020, THE LIFEVEST DETECTED VT AND VENTRICULAR FIBRILLATION (VF) AND DELIVERED A SECOND APPROPRIATE TREATMENT. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 50 BPM. THEN AT 03:06:13 AND 03:06:38, THE PATIENT RECEIVED TWO INAPPROPRIATE TREATMENTS DURING ASYSTOLE. ASYSTOLE IS A NON-TREATABLE RHYTHM. POSSIBLE CPR/MOTION ARTIFACT AND OVERSENSING OF LOW AMPLITUDE CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE PATIENT REPORTEDLY PASSED AWAY ON (B)(6) 2020 AT APPROXIMATELY 3:45 AM. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. DURING THE INVESTIGATION OF THE PATIENT'S ELECTRODE BELT FOLLOWING THE EVENT, A REPORTABLE MALFUNCTION WAS FOUND.