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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAMERON HEALTH SQ-RX PULSE GENERATOR; IMPLANTABLE DEVICE
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CAMERON HEALTH SQ-RX PULSE GENERATOR; IMPLANTABLE DEVICE Back to Search Results
Model Number 1010
Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
 
Event Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) went from a battery status of 40% remaining to 9% remaining in one year.Additionally, the device recorded a battery depletion message.Boston scientific technical services (ts) requested a copy of a device memory for analysis.Available information indicates this product remains implanted and in service.No adverse patient effects were reported.
 
Manufacturer Narrative
The returned s-icd was analyzed and a review of device memory did not identify any batter depletion messages.The device case was removed to facilitate inspection of the internal components.Visual examination of the interior identified no anomalies.Detailed analysis identified an internal battery short that resulted in the observed depletion.Note that the sq-rx (model 1010) s-icd is the only boston scientific device manufactured with a battery potentially susceptible to this particular issue.The sq-rx device is no longer manufactured; the current generation of s-icds contain a different battery (manufactured by boston scientific).This device was included in the november 2018 sq-rx model 1010 pg shortened replacement interval advisory population.Patient code 3191 used to address the surgical intervention that was undertaken.
 
Event Description
It was reported that the device was explanted and replaced.No additional adverse patient effects were reported.
 
Event Description
It was reported that the device was explanted and replaced.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.Patient code 3191 used to address the surgical intervention that was undertaken.
 
Event Description
It was reported that a copy of device memory was received.Analysis of device memory confirmed that the battery depletion message was valid.Boston scientific technical services (ts) recommended device replacement.Available information indicates this device remains implanted and in service.No adverse patient effects were reported.This device was included in the november 2018 sq-rx model 1010 pg shortened replacement interval advisory population.
 
Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
 
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Brand Name
SQ-RX PULSE GENERATOR
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
CAMERON HEALTH
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9597540
MDR Text Key175263576
Report Number2124215-2019-25359
Device Sequence Number1
Product Code LWS
UDI-Device Identifier00802526562808
UDI-Public00802526562808
Combination Product (y/n)N
PMA/PMN Number
P110042/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup
Report Date 03/24/2020
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? Yes
Device Operator Lay User/Patient
Device Expiration Date06/29/2015
Device Model Number1010
Device Catalogue Number1010
Device Lot NumberA014452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received01/16/2020
Supplement Dates Manufacturer Received11/25/2019
01/02/2020
02/04/2020
Supplement Dates FDA Received01/26/2020
03/24/2020
03/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0474-2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age47 YR
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