PROPONENT MRI SR
Report
- Report Number
- 2124215-2022-07983
- Event Type
- Injury
- Date Received
- April 16, 2022
- Date of Event
- March 1, 2022
- Report Date
- November 4, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- PMA / PMN Number
- P150012/S000
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WILL BE UPDATED AT THAT TIME.
THE COMPLAINT DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER; THEREFORE, NO PRODUCT ANALYSIS COULD BE PERFORMED. THE COMPLAINT INVESTIGATION CONCLUSION CODE IS "NO PROBLEM DETECTED". CORRECTION: 1. PATIENT IDENTIFIER NUMBER WAS ADDED TO THE "PATIENT INFORMATION" TAB. 2. DEVICE SERIAL NUMBER (SUSPECT MEDICAL DEVICE TAB): THE CORRECT MODEL/SERIAL NUMBER OF THE DEVICE INVOLVED IN THE COMPLAINT IS L210/706186 AND NOT L210/832430. THE PREVIOUS REPORTS INCLUDED THE SERIAL NUMBER (B)(6), WHICH IS THE ONE FOR THE REPLACEMENT PRODUCT.
THE COMPLAINT DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER; THEREFORE, NO PRODUCT ANALYSIS COULD BE PERFORMED. THE COMPLAINT INVESTIGATION CONCLUSION CODE IS "NO PROBLEM DETECTED". CORRECTION: 1. PATIENT IDENTIFIER NUMBER WAS ADDED TO THE "PATIENT INFORMATION" TAB. 2. DEVICE SERIAL NUMBER (SUSPECT MEDICAL DEVICE TAB): THE CORRECT MODEL/SERIAL NUMBER OF THE DEVICE INVOLVED IN THE COMPLAINT IS (B)(6) AND NOT (B)(6). THE PREVIOUS REPORTS INCLUDED THE SERIAL NUMBER 832430, WHICH IS THE ONE FOR THE REPLACEMENT PRODUCT. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. A HIGH CURRENT DRAIN WAS DETECTED, BUT THE BATTERY STILL SUPPORTED FULL DEVICE FUNCTION. DETAILED ANALYSIS CONFIRMED THE IDENTIFIED HIGH CURRENT DRAIN WAS A RESULT OF COMPROMISED CAPACITORS. THIS RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION. IT WAS DETERMINED THAT THE CAPACITORS WERE COMPROMISED DUE TO THE PRESENCE OF EXCESS HYDROGEN IN THE DEVICE CASE. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE REGARDING A SUBSET OF DEVICES IN THE ACCOLADE PACEMAKER FAMILY THAT HAVE A POTENTIAL OF EXHIBITING THIS BEHAVIOR. THIS PARTICULAR DEVICE IS INCLUDED IN THE HYDROGEN INDUCED PREMATURE DEPLETION ADVISORY POPULATION.
THE COMPLAINT DEVICE HAS NOT BEEN RETURNED BY THE CUSTOMER; THEREFORE, NO PRODUCT ANALYSIS COULD BE PERFORMED. THE COMPLAINT INVESTIGATION CONCLUSION CODE IS "NO PROBLEM DETECTED". PATIENT IDENTIFIER NUMBER WAS ADDED TO THE "PATIENT INFORMATION" TAB.
IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY AS A SUDDEN LONGEVITY DROP WAS IDENTIFIED. CONSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED AS IT ONLY HAD FOUR MONTHS LEFT OF BATTERY CAPACITY. THE TIMEFRAME IN WHICH THE ESTIMATED LONGEVITY CHANGE WAS OBSERVED HAS NOT BEEN SPECIFIED. AT THIS TIME, THERE IS NO EVIDENCE THAT SUGGESTS DATA ANALYSIS WAS PERFORMED PRIOR TO THE EXPLANT PROCEDURE TO CONFIRM THE PREMATURE BATTERY DEPLETION (PBD) OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.
IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY AS A SUDDEN LONGEVITY DROP WAS IDENTIFIED. CONSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED AS IT ONLY HAD FOUR MONTHS LEFT OF BATTERY CAPACITY. THE TIMEFRAME IN WHICH THE ESTIMATED LONGEVITY CHANGE WAS OBSERVED HAS NOT BEEN SPECIFIED. AT THIS TIME, THERE IS NO EVIDENCE THAT SUGGESTS DATA ANALYSIS WAS PERFORMED PRIOR TO THE EXPLANT PROCEDURE TO CONFIRM THE PREMATURE BATTERY DEPLETION (PBD) OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.
IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY AS A SUDDEN LONGEVITY DROP WAS IDENTIFIED. CONSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED AS IT ONLY HAD FOUR MONTHS LEFT OF BATTERY CAPACITY. THE TIMEFRAME IN WHICH THE ESTIMATED LONGEVITY CHANGE WAS OBSERVED HAS NOT BEEN SPECIFIED. AT THIS TIME, THERE IS NO EVIDENCE THAT SUGGESTS DATA ANALYSIS WAS PERFORMED PRIOR TO THE EXPLANT PROCEDURE TO CONFIRM THE PREMATURE BATTERY DEPLETION (PBD) OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS BUT HAS YET TO ARRIVE TO THE POST MARKET QUALITY ASSURANCE LABORATORY. SEVERAL ADDITIONAL ATTEMPTS WERE MADE TO RETRIEVE THE PRODUCT, BUT NO RESPONSE HAS BEEN RECEIVED YET. THE DEVICE WAS RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY AS A SUDDEN LONGEVITY DROP WAS IDENTIFIED. CONSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED AS IT ONLY HAD FOUR MONTHS LEFT OF BATTERY CAPACITY. THE TIMEFRAME IN WHICH THE ESTIMATED LONGEVITY CHANGE WAS OBSERVED HAS NOT BEEN SPECIFIED. AT THIS TIME, THERE IS NO EVIDENCE THAT SUGGESTS DATA ANALYSIS WAS PERFORMED PRIOR TO THE EXPLANT PROCEDURE TO CONFIRM THE PREMATURE BATTERY DEPLETION (PBD) OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2414489 | PROPONENT MRI SR | PACEMAKER | LWP | BOSTON SCIENTIFIC CORPORATION | L210 | 706186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |