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MEDTRONIC, INC. · Model TH91D01 · UDI-DI 00763000424114

MRUPJSNHLMBXMHYOLM Prescription
0
510(k) clearances
2,909
Adverse events (16 deaths)
2
Recalls
9
Facilities

Description

COMM HANDSET KIT TH91D01 DBS A10E PPR EN

Recalls

DateFirmReason
2022-03-30Medtronic NeuromodulationThe Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
2013-02-08Medtronic NeuromodulationThere is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits. Medtronic has received reports of DBS leads being damaged at the connector e

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.