Featured HeartNet Reports of Interest
MedSun: Newsletter #61, June 2011

Your reports of actual adverse events, and more importantly, reports of 'potential for harm', 'near miss', and 'close call' medical device related safety concerns are of special interest to FDA, MedSun and HeartNet. The following four events reported by MedSun HeartNet facilities contributed to two manufacturer actions:

The first reported event is associated with a Class II recall.

1. Featured MedSun HeartNet Report
Type of device: Pacemaker, Implantable
Device brand name: Adapta DR
Device manufacturer's name: Medtronic, Inc.
Date of this report: 07/02/2010

Describe the event or problem: Pacemaker checked via trans-telephonic monitoring and found to be demonstrating elective replacement behavior. The last clinic visit from three months ago had battery with estimated longevity of 7.5 years. The clinic visit today confirmed elective replacement behavior. The company was contacted for troubleshooting. Technical support indicated this is known issue that is remedied by a "special lab programmer". The condition is in the hardware for measurements. The device locks up and returns a battery voltage of zero and measurements are affected, after 12 hours, the device goes to ERI. The software fix will only unlock the hardware issue, however there is no indication thus far whether the issue will resurface. They have unlocked 12 devices so far and of those none have had a re-occurrence. If patient develops pacemaker syndrome, Medtronic recommends device change out. The programmer is being shipped to the local representative within the month. The patient was evaluated and found to be asymptomatic and verbalized understanding of symptoms that require immediate attention. The patient was discharged to home.
=======Health Professional's Impression =======
No adverse event as yet.

Related Recall: Please see the following Class 2 recall for the affected Implantable Pulse Generators manufactured by Medtronic. To read the FDA recall notice, see link provided below:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99504

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The following three events reported by MedSun HeartNet facilities are associated with a Class III recall.

2. Featured MedSun HeartNet Report
Type of device: compressor, external, cardiac
Device brand name: AutoPulse
Device manufacturer's name: Zoll Medical Corporation
Date of this report: 12/31/2010

Describe the event or problem: The AutoPulse was initiated for chest compressions during a resuscitation attempt. A freshly charged battery had been placed in the device 8 hours earlier. Another battery had been placed in the charger at that time. During the resuscitation, the device functioned for 2-3 minutes. Manual compressions were initiated. The first battery was then replaced with one that had been charged. After replacing the battery, the device functioned for only 3-5 minutes. Manual compressions were initiated and used for the duration of the resuscitation. After the second battery was placed, the device prompted the operator to start-restart-start continuously. Both batteries indicated a low battery warning on the AutoPulse while in use even though they had been charged. When the operator was unable to get the device to work they attempted to re-boot it. They were unable to turn the device back on from the "off state".

3. Featured MedSun HeartNet Report
Type of device: compressor, cardiac external
Device brand name: AutoPulse
Device manufacturer's name: Zoll Medical Corporation
Date of this report: 12/31/2010

Describe the event or problem: The AutoPulse device was initiated for chest compressions during resuscitation. The AutoPulse device functioned for approximately 5 minutes before it quit. Manual compressions were then initiated. The battery was replaced and the AutoPulse used again but the device only operated for 2-3 minutes. Manual compressions were resumed and used for the duration of resuscitation.

4. Featured MedSun HeartNet Report
Type of device: compressor, external, cardiac, powered
Device brand name: Autopulse Non-invasive Cardiac support pump
Device manufacturer's name: Zoll
Date of this report: 10/19/2010

Describe the event or problem: A middle-aged patient was coding in the cardiac cath lab. Attempted to use the Zoll Autopulse. Device did not work. All batteries were drained of power. All batteries were used and each only provided approximately five compressions and then failed. According to the Zoll rep, we have been changing out the batteries every day and draining/charging as instructed. Patient required mannual compressions for over an hour.
=======Health Professional's Impression =======
Current battery conditioner/charger is not putting the proper load test on the batteries to stimulate real life usage.

Related Recall: Please see the following Class III recall for the affected Auto Pulse Resuscitation System manufactured by Zoll. To read the FDA recall notice, see link provided below:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98342

Additional Information:

1. Featured MedSun HeartNet Report. July 2, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%5DS9%25%5FL%20%0A&CFID=57608596&CFTOKEN=8c150327834c96ad-DBDA630

Class II Recall Medtronic Implantable Pulse Generators. April 29, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99504

2. Featured MedSun HeartNet Report. December 31, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5D%5F%3E%26%2FT%20%0A

3. Featured MedSun HeartNet Report. December 31, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5D%5F%3E%26%2FH%20%0A

4. Featured MedSun HeartNet Report. October 19, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5D%5B%3E%26%3F%3C%20%0A

Class III recall Zoll AutoPulse Resuscitation System. April 7, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98342


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