Recall Z-0418-2022
Medtronic Neuromodulation · initiated October 19, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Codes / lots: GTIN 00763000253363, Serial Numbers: NPI714835H, NPI714811H, NPI714812H, NPI714814H, NPI714816H, NPI714817H, NPI714819H, NPI714820H, NPI714750H, NPI714764H, NPI714771H, NPI714794H, NPI714682H, NPI714709H, NPI714710H, NPI714594H, NPI714598H, NPI714599H, NPI714602H, NPI714603H, NPI714606H, NPI714564H, NPI714572H, NPI714574H, NPI714587H, NPI714588H, NPI714589H, NPI714373H, NPI714379H, NPI714331H, NPI714346H, NPI714358H, NPI714378H, NPI714128H, NPI714160H, NPI714060H, NPI713947H, NPI713956H, NPI713957H, NPI714001H, NPI714017H, NPI713948H, NPI713949H, NPI713951H, NPI713952H, NPI713953H, NPI713954H, NPI713955H, NPI713829H, NPI713371H, NPI713372H, NPI713422H, NPI713242H, NPI713188H, NPI712940H, NPI712785H, NPI712637H, NPI712405H, NPI712411H, NPI712412H, NPI712341H, NPI712302H, NPI712256H, NPI711876H, NPI711841H, NPI711475H, NPI711476H, NPI710876H, NPI710765H, NPI710561H, NPI710071H, NPI709964H, NPI709680H, NPI709654H, NPI709655H, NPI709575H, NPI708692H, NPI708699H, NPI708702H, NPI708709H, NPI708675H, NPI708653H, NPI708635H, NPI708457H, NPI708415H, NPI708417H, NPI708425H, NPI708367H, NPI708376H, NPI708358H, NPI708316H, NPI708288H, NPI708289H, NPI708292H, NPI708295H, NPI708299H…
Reason for recall
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
FDA-determined cause: Under Investigation by firm
Action taken
Medtronic distributed a correction notice via mail courier service to impacted U.S. consignees, delivered 06-October-2021. A second attempt to notify US consignees is scheduled for the week of 08-November-2021. A third attempt to notify US consignees is scheduled for the week of 10-Jan-2022. In addition to Medtronic s communications to Percept PC implanting and managing physicians, Medtronic will notify affected patients implanted with Percept PC INS devices of this issue in the US. US Patient notifications are scheduled to happen within a month s timeframe. Medtronic will retain delivery confirmations for all patient notification mailings.
Details
- Recall number
- Z-0418-2022
- Initiated
- October 19, 2021
- Product code
- MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Quantity
- 10,006 units
- Distribution
- Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, India, Japan, Korea, Republic Of, Argentina…
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN